Hyphen BioMed

Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2

Hematology and Pathology Devices

2

No

OH, MD, NC, NY, NH, Canada, Sweden

ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.

Lot numbers: F1600568P1, F1701370P1, F1701370P2

Hematology and Pathology Devices

2

No

OH, MD, NC, NY, NH, Canada, Sweden

ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

Lot numbers: F1701084P2 and F1701084P3

Hematology and Pathology Devices

2

No

OH, MD, NC, NY, NH, Canada, Sweden

ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.

UDI: 03663537046810. Lot Number: F1700416.

Hematology and Pathology Devices

2

No

Worldwide Distribution - US Distribution and to the countries of : Austria and France.

ZYMUTEST HIA MonoStrip IgGAM. || Model Number: RK041D. || Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

UDI: 03663537018770 Lot Number: F1700415

Hematology and Pathology Devices

2

No

Worldwide Distribution - US Distribution and to the countries of : Austria and France.

ZYMUTEST HIA IgGAM. || Model Number: RK040D. || Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.