IDS-i10

GUDID 05060169693968

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD Multichannel immunoassay analyser IVD
Primary Device ID05060169693968
NIH Device Record Key8a56e9af-dd99-4182-8fb2-bf6f598b3de3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-i10
Version Model NumberIS-810400
Company DUNS494268600
Company NameIMMUNODIAGNOSTIC SYSTEMS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com
Phone+4401915190660
Emailtechsupport.uk@idsplc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169693968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-05
Device Publish Date2023-06-27

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05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set2024-01-11
05060169696457 - IDS ACTH II2023-08-31
05060169696495 - IDS ACTH II Calibrator Set2023-08-31
05060169696532 - IDS ACTH II Control Set2023-08-31
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