IMMUCOR, INC.

Address:3130 GATEWAY DR.,Norcross,GA,30071,US

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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

Reagent Red Blood Cells (QHT) (1)

Premarket Exempt

No Yes

Clear

Anti-Fyb (Monoclonal) Gamma-clone - 10888234002383 Catalog Number : 0004818

Device Description : Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the det Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Anti-k (Monoclonal) (IgG) Gamma-clone - 10888234002390 Catalog Number : 0004817

Device Description : Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Panoscreen EXTEND - 10888234002406 Catalog Number :

Device Description : Panoscreen EXTEND is intended for use in the detection of unexpected red blood c Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.

Device Class : U

Duns Number: 061446282

Premarket Exempt : No

Product Code : QHT

Prescription Use : Yes

Device Count : 1

Anti-s (Monoclonal) Gamma-clone - 10888234002420 Catalog Number : 0066429

Device Description : Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Anti-S (Monoclonal) Gamma-clone - 10888234002437 Catalog Number : 0066428

Device Description : Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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