CAPILLARYS HEMOGLOBIN 2007

GUDID 03607360020074

Device that detects and measure hemoglobin variants using capillary electrophoresis

SEBIA

Multiple haemoglobin subtype IVD, kit, electrophoresis
Primary Device ID03607360020074
NIH Device Record Key3930d8a4-c7fc-411c-b876-99b818e8d9b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPILLARYS HEMOGLOBIN
Version Model Number2007
Catalog Number2007
Company DUNS276801933
Company NameSEBIA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
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 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103607360020074 [Primary]

FDA Product Code

GKAAbnormal Hemoglobin Quantitation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2018-01-24

Devices Manufactured by SEBIA

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03607360025062 - CAPI 3 NEONAT Hb2024-05-08
03607360025635 - CAPI 3 NEONAT HEMOLYSING SOLUTION2024-05-08
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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