ALBA BIOSCIENCE LIMITED

Address:5 JAMES HAMILTON WAY,PENICUIK Midlothian,GB

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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) (1)

Premarket Exempt

No Yes

Clear

AlbaQ-Chek® - 05060242470943 Catalog Number :

Device Description : AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques.

Device Class : 2

Duns Number: 516536641

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ALBAsera Anti-K - 05060242470967 Catalog Number :

Device Description : Blood Grouping Reagent, ALBA-sera Anti-K (Polyclonal) for indirect antiglobulin Blood Grouping Reagent, ALBA-sera Anti-K (Polyclonal) for indirect antiglobulin test by tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAsera Anti-Fya - 05060242470974 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAsera Anti-Fya (Polyclonal) for indirect antiglobulin Blood Grouping Reagent, ALBAsera Anti-Fya (Polyclonal) for indirect antiglobulin test by tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAsera Anti-Fyb - 05060242470981 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAsera Anti-Fyb (Polyclonal) for indirect antiglobulin Blood Grouping Reagent, ALBAsera Anti-Fyb (Polyclonal) for indirect antiglobulin test by tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-M - 05060242470998 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-M (Murine Monoclonal IgG) for tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-N - 05060242471001 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-N (Murine Monoclonal IgG) for tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAsera Anti-s - 05060242471018 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAsera Anti-s (Polyclonal) for indirect antiglobulin t Blood Grouping Reagent, ALBAsera Anti-s (Polyclonal) for indirect antiglobulin test by tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-Lea - 05060242471025 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-Lea (Murine Monoclonal IgM) for tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-Lub - 05060242471032 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-Lub (Murine Monoclonal IgG) for tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-Leb - 05060242471049 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-Leb (Murine Monoclonal IgM) for tube technique.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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