IMMUCOR GTI DIAGNOSTICS, INC.

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

Test,Platelet Antibody (MYP) (7) Test,Qualitative,For Hla,Non-Diagnostic (MZI) (2) Test, Qualitative, For Hla, Non-Diagnostic (MZI) (1)

Premarket Exempt

Clear

3 x 4% E-Gel 48 Gels - 10888234500667 Catalog Number : EGEL48

Device Description : For Use with ThromboType and ThromboType1

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1

PakPlus® - 10888234500674 Catalog Number : PAKPLUS100

Device Description : The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/II.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : Yes

Device Count : 1

Concentrated Wash (10X) - 10888234500681 Catalog Number : 404562

Device Description : For Use with PakPlus100

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1

Stopping Solution - 10888234500698 Catalog Number : 404585

Device Description : For Use with PakPlus100

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1

Specimen Diluent - 10888234500704 Catalog Number : 404582

Device Description : For Use with PakPlus100

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1

Substrate Buffer - 10888234500711 Catalog Number : 404587

Device Description : For Use with PakPlus100

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1

PakAuto® - 10888234500728 Catalog Number : PAKAUTO-MAYO

Device Description : PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (EL PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : MYP

Prescription Use : No

Device Count : 1

LIFECODES MATCH IT!™ DNA Software v1.3 - 10888234500803 Catalog Number : 888623

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

LIFECODES MATCH IT! Antibody Software v1.4 - 10888234500810 Catalog Number : 888627

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Dilution Solution - 10888234500827 Catalog Number : 628515UDI

Device Description : For Use with HLA-SSO Typing Kits

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

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