CAPI 3 NEONAT Hb AF Control 4757

GUDID 03607360047576

SEBIA

Haemoglobin detection IVD, control
Primary Device ID03607360047576
NIH Device Record Keybbb53622-d35a-42be-8c92-39345f632045
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPI 3 NEONAT Hb AF Control
Version Model Number4757
Catalog Number4757
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 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
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This Way Up_Fragile-Handle with care_Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS103607360047576 [Primary]

FDA Product Code

JCMControl, Hemoglobin, Abnormal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

Devices Manufactured by SEBIA

03607360012444 - CAPILLARYS 3 DBS2024-05-08 INSTRUMENT
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
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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