IDS-iSYS Multi Discipline Automated System

GUDID 05060169691223

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID05060169691223
NIH Device Record Keyafed2d37-23a8-4c48-94dd-f40dfb59325a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-iSYS Multi Discipline Automated System
Version Model NumberIS-310400
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The analyser must be stored in its original packaging under the specified storage conditions for up to 2 months
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169691223 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-23
Device Publish Date2016-04-01

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