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, Cell Screening, Fetal (MTI) (1)

Premarket Exempt

No Yes

Clear

ALBAclone Anti-Jkb (Monoclonal) - 05060242472510 Catalog Number :

Device Description : This Anti-Jkb reagent is for the in vitro detection and identification of the hu This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

FETALSCREEN™II - 10758750006144 Catalog Number :

Device Description : FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red bl FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code : MTI

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-Fya - 10758750013005 Catalog Number :

Device Description : The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of hum The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirectantiglobulin test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-Fyb - 10758750013012 Catalog Number :

Device Description : The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of hum The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirectantiglobulin test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-Jka - 10758750013029 Catalog Number :

Device Description : The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of hum The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the directagglutination test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-Jkb - 10758750013036 Catalog Number :

Device Description : The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of hum The Anti-Jkb reagent (Anti-JK2) is for the qualitative in vitro detection of human Jkb positive red blood cells by the directagglutination test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-S - 10758750013043 Catalog Number :

Device Description : The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of huma The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirectantiglobulin test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-s - 10758750013050 Catalog Number :

Device Description : The Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of huma The Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of human s positive red blood cells by the indirectantiglobulin test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-D (IAT) Blood Grouping Reagent - 10758750013067 Catalog Number :

Device Description : The Anti-D (IAT) reagent (Anti-RH1) is for the qualitative in vitro detection of The Anti-D (IAT) reagent (Anti-RH1) is for the qualitative in vitro detection of human RhD positive red blood cells by the indirect antiglobulin test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ORTHOTM Sera Anti-K - 10758750013074 Catalog Number :

Device Description : The Anti-K reagent (KEL1) is for the qualitative in vitro detection of human K p The Anti-K reagent (KEL1) is for the qualitative in vitro detection of human K positive red blood cells by the direct agglutination test.

Device Class :

Duns Number: 516536641

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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