IDS-iSYS Ostase® BAP Calibration Verifiers

GUDID 05060169695825

IMMUNODIAGNOSTIC SYSTEMS LIMITED

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Primary Device ID05060169695825
NIH Device Record Keydaa4b2de-1531-4900-8986-4acaf206e443
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDS-iSYS Ostase® BAP Calibration Verifiers
Version Model NumberIS-2835US
Company DUNS494268600
Company NameIMMUNODIAGNOSTIC SYSTEMS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com
Phone+4401915190663
Emailtechsupport.uk@idsplc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the calibration verifiers in an upright position at 2 - 8 °C.

Device Identifiers

Device Issuing AgencyDevice ID
GS105060169695825 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-16
Device Publish Date2021-03-08

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