MINICAP HEMOGLOBIN 2207

GUDID 03607360022078

Device used to measure hemoglobin variants

SEBIA

Multiple haemoglobin subtype IVD, kit, electrophoresis
Primary Device ID03607360022078
NIH Device Record Keya91dab6d-3323-4b5b-b3ba-09f910f4bdec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMINICAP HEMOGLOBIN
Version Model Number2207
Catalog Number2207
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 Usefalse
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
GS103607360022078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2022-06-10
Device Publish Date2018-01-24

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03607360026021 - Sample Diluent CAPI 3 IT (10)2023-12-07

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