IMMUCOR, INC.

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

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- Catalog Number : 0007861

Device Description : Gamma ELU-KIT II is intended for use in the rapid acid elution of antibodies fro Gamma ELU-KIT II is intended for use in the rapid acid elution of antibodies from intact red blood cells.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0007865

Device Description : Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0007890

Device Description : Gamma-Quin is intended for use in removing red cell-bound immunoglobulin. Gamma- Gamma-Quin is intended for use in removing red cell-bound immunoglobulin. Gamma-Quin is an approximately 16% solution of chloroquine diphosphate in phosphate-buffered saline at a pH of about 5.0. This package configuration is one (1) vial of 10 mL volume.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSK

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0007893

Device Description : The FMH RapidScreen kit is intended for use in the detection of D-positive red b The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : LIM

Prescription Use : Yes

Device Count : 1

Device Description : Complement Control Cells are used in confirming reactivity of the anti-C3 compon Complement Control Cells are used in confirming reactivity of the anti-C3 component of Anti-Human Globulin, as a control mechanism for the antiglobuilin test. This product is a one (1) vial configuration.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : Yes

Product Code : KSF

Prescription Use : Yes

Device Count : 1

Device Description : Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiat Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0057292

Device Description : Freeze Dried Papain is used as a proteolytic enzyme in serological tests. The pa Freeze Dried Papain is used as a proteolytic enzyme in serological tests. The papain enzyme is derived from Carica papaya. The product configuration is ten (10) vials.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSK

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0057316

Device Description : RESt (Rabbit Erythrocyte Stroma) is used to adsorb cold reactive autoagglutins s RESt (Rabbit Erythrocyte Stroma) is used to adsorb cold reactive autoagglutins such as anti-I, anti-H or anti-IH, for human serum or plasma to facilitate the resolution of serological complexities. RESt contains a saline suspension of rabbit erythrocyte stroma. This package configuration is eight (8) tube tests.

Device Class : 1

Duns Number: 061446282

Premarket Exempt : Yes

Product Code : LSQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0057319

Device Description : W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reac W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : KSK

Prescription Use : Yes

Device Count : 1

Device Description : H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activit H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials.

Device Class : 2

Duns Number: 061446282

Premarket Exempt : No

Product Code : MYP

Prescription Use : Yes

Device Count : 1