IMMUCOR GTI DIAGNOSTICS, INC.

Address:20925 Crossroads Cir,Waukesha,WI,53186,US

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Device Description : The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immun The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

- Catalog Number : X-HAT13

Device Description : PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assa PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : LCO

Prescription Use : Yes

Device Count : 1

- Catalog Number : X-HAT45

Device Description : PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assa PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : LCO

Prescription Use : Yes

Device Count : 1

- Catalog Number : HAT13G

Device Description : PF4 IgG is a qualitative screening assay for the detection of heparin associated PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : LCO

Prescription Use : Yes

Device Count : 1

- Catalog Number : HAT45G

Device Description : PF4 IgG is a qualitative screening assay for the detection of heparin associated PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : LCO

Prescription Use : Yes

Device Count : 1

Device Description : LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorben LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class II antigens.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : KSZ

Prescription Use : No

Device Count : 1

Device Description : LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorb LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : No

Device Count : 1

Device Description : DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immuno DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : No

Device Count : 1

Device Description : DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immuno DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : No

Device Count : 1

- Catalog Number : PAK12

Device Description : Pak12 assay is a qualitative solid phase enzyme linked immunosorbent assay (ELIS Pak12 assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1