ALBA BIOSCIENCE LIMITED

Address:5 JAMES HAMILTON WAY,PENICUIK Midlothian,GB

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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

Media, Potentiating For In Vitro Diagnostic Use (KSG) (2) Kit, Quality Control For Blood Banking Reagents (KSF) (1) Solution, Stabilized Enzyme (KSK) (1)

Premarket Exempt

No Yes

Clear

ALBAclone Anti-D blend - 05060242471452 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-D blend (Human/Murine Monoclonal IgM/IgG) Blood Grouping Reagent, ALBAclone Anti-D blend (Human/Murine Monoclonal IgM/IgG) for slide and tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-E - 05060242471469 Catalog Number :

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

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-c - 05060242471476 Catalog Number :

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

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-D alpha - 05060242471483 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-D alpha (Human/Murine Monoclonal IgM) for Blood Grouping Reagent, ALBAclone Anti-D alpha (Human/Murine Monoclonal IgM) for slide and tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-D beta - 05060242471490 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-D beta (Human/Murine Monoclonal IgM) for Blood Grouping Reagent, ALBAclone Anti-D beta (Human/Murine Monoclonal IgM) for slide and tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAclone Anti-D delta - 05060242471506 Catalog Number :

Device Description : Blood Grouping Reagent, ALBAclone Anti-D delta (Human/Murine Monoclonal IgM/IgM) Blood Grouping Reagent, ALBAclone Anti-D delta (Human/Murine Monoclonal IgM/IgM) for slide and tube techniques.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ALBAcheck BGS Reagent Control for Anti-D - 05060242471513 Catalog Number :

Device Description : ALBAcheck BGS Reagent Control for Anti-D.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

Bovine Serum Albumin 22% - 05060242471520 Catalog Number :

Device Description : Bovine Serum Albumin 22%.

Device Class :

Duns Number: 516536641

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : No

Device Count : 1

ALBAhance PEG - 05060242471537 Catalog Number :

Device Description : ALBAhance PEG for the potentiation of indirect antiglobulin tests.

Device Class :

Duns Number: 516536641

Premarket Exempt : Yes

Product Code : KSG

Prescription Use : No

Device Count : 1

ALBAhance LISS Additive Reagent - 05060242471544 Catalog Number :

Device Description : ALBAhance LISS Additive Reagent.

Device Class :

Duns Number: 516536641

Premarket Exempt : Yes

Product Code : KSK

Prescription Use : No

Device Count : 1

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