AMERICAN NATIONAL RED CROSS

AMERICAN NATIONAL RED CROSS

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Kit, Quality Control For Blood Banking Reagents (KSF) (2)

Premarket Exempt

No Yes

Clear

Anti-K - 00858400005008 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-k - 00858400005015 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-Kpa - 00858400005022 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-Kpb - 00858400005039 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-M - 00858400005046 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-S - 00858400005053 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-s - 00858400005060 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Anti-Fya - 00858400005077 Catalog Number :

Device Description : Blood Grouping Reagent

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

DailyChek QC Kit - 00858400005084 Catalog Number :

Device Description : Blood Bank kit used to perform quality control testing of reverse grouping and s Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells.

Device Class : 2

Duns Number: 003255213

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

Control Cells - 00858400005091 Catalog Number :

Device Description : IgG-coated red blood cells used to confirm negative results in direct antiglobul IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).

Device Class :

Duns Number: 003255213

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

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