CAPI 3 CDT 2509

GUDID 03607360025093

CARBOHYDRATE DEF TRANSFERRIN BY CE

SEBIA

Transferrin/transferrin isoform IVD, kit, electrophoresis
Primary Device ID03607360025093
NIH Device Record Key5f587ced-cf92-4271-a38e-13088ce364f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPI 3 CDT
Version Model Number2509
Catalog Number2509
Company DUNS276801933
Company NameSEBIA
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 Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP

Device Identifiers

Device Issuing AgencyDevice ID
GS103607360025093 [Primary]

FDA Product Code

NAOTest, Carbohydrate Deficient Transferrin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-13
Device Publish Date2022-12-08

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03607360025789 - CAPILLARYS 3 DBS MICROPLATES2024-05-08 MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
03607360047576 - CAPI 3 NEONAT Hb AF Control2024-05-08
03607360047927 - Hb AFSC Control2024-05-08
03607360026014 - ANTISERA CAPI 3 IT (10)2023-12-07
03607360026021 - Sample Diluent CAPI 3 IT (10)2023-12-07

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