IMMUCOR, INC.

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

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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

Diluent, Blood Cell (GIF) (1) Ph Buffer (JCC) (1) Supplies, Blood-Bank (KSS) (1)

Premarket Exempt

No Yes

Clear

Anti-C3b,-C3d (Murine Monoclonal) Gamma-clone - 10888234000402 Catalog Number : 0004068

Device Description : This reagent is used in direct antiglobulin tests where the detection of C3 (as This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. 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 (Human Monoclonal) Series 2 - 10888234000440 Catalog Number : 0004210

Device Description : This reagent is used for the detection of the K 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-P1 (Murine Monoclonal) Gamma-clone - 10888234000457 Catalog Number : 0004501

Device Description : This reagent is intended for the detection of the P1 antigen on red blood cells This reagent is intended for the detection of the P1 antigen 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

Anti-M (Murine Monoclonal) Gamma-clone - 10888234000464 Catalog Number : 0004802

Device Description : This reagent is intended for the detection of the M antigen on red blood cells b This reagent is intended for the detection of the M antigen on red blood cells by tube test.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Di(a+) Cell - 10888234000471 Catalog Number : 0005021

Device Description : Di(a+) Cell is used in the detection of unexpected red blood cell blood group an Di(a+) Cell is used in the detection of unexpected red blood cell blood group antibodies. Di(a+) Cell is a single vial of group O, Di(a+) red blood cells.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Platelet Wash and Storage Solution - 10888234000488 Catalog Number : 0005035

Device Description : Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store pla Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.

Device Class : 1

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

Red Blood Cell (RBC) Storage Solution - 10888234000495 Catalog Number : 0005036

Device Description : Red Blood Cell (RBC) Storage Solution is a general purpose reagent intended for Red Blood Cell (RBC) Storage Solution is a general purpose reagent intended for use in suspending and preserving red blood cells that can be subsequently used for in vitro immunohematology testing. Red Blood Cell (RBC) Storage Solution is a buffered preservation solution containing adenosine and adenine to retard hemolysis and/or loss of antigenicity. The product is a one (1) liter bag configuration.

Device Class : 1

Duns Number: 061446282

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : Yes

Device Count : 1

pHix - 10888234000501 Catalog Number : 0005070

Device Description : This product is phosphate buffer concentrate and is used to buffer saline used i This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box.

Device Class : 1

Duns Number: 061446282

Premarket Exempt : No

Product Code : JCC

Prescription Use : Yes

Device Count : 1

Anti-A (Murine Monoclonal) Series 1 - 10888234000525 Catalog Number : 0006400

Device Description : Anti-A (Murine Monoclonal) Series 1 is intended for use in slide, tube, micropla Anti-A (Murine Monoclonal) Series 1 is intended for use in slide, tube, microplate and automated tests, for the detection of the A antigen.

Device Class :

Duns Number: 061446282

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Anti-B (Murine Monoclonal) Series 3 - 10888234000532 Catalog Number : 0006406

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

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