IMMUCOR, INC.

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

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Device Description : This reagent is used in slide, tube, microplate and automated tests, for the det This reagent is used in slide, tube, microplate and automated tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is one (1) vial of reagent.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, micropla Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplat Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplat Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0006418

Device Description : Capture LISS is for use as a low ionic strength potentiator and sample addition Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the single 57 mL bottle version.

Device Class : 1

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0066216

Device Description : Capture-CMV is an in vitro qualitative solid phase red cell adherence test syste Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of donors or patients for serological evidence of previous infection by CMV. This is the five plate product.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : LJO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0066087

Device Description : Monoclonal Control is intended to be used as a control for Immucor low protein B Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has one (1) vial.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSF

Prescription Use : Yes

Device Count : 1

Device Description : This reagent is used for the detection of the Jka antigen (of the Kidd blood gro This reagent is used for the detection of the Jka antigen (of the Kidd blood group system) on red blood cells by 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

Device Description : This monoclonal reagent is used for the detection of the Jkb antigen (of the Kid This monoclonal reagent is used for the detection of the Jkb antigen (of the Kidd blood group system) on red blood cells by 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

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