Affinity Biologicals Inc

VisuLize Factor FVIII Antigen Kit - 10629009010000 Catalog Number :

Device Description : 96 Test enzyme immunoassay kit for the determination of FVIII Antigen

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 1

VisuLize Factor FIX Antigen Kit - 10629009020009 Catalog Number :

Device Description : 96 Test enzyme immunoassay kit for the determination of FIX Antigen

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 1

VisuCon-F Low Fibrinogen Control Plasma - 10629009031050 Catalog Number :

Device Description : Assayed control plasma prepared from de-fibrinated human plasma intended for use Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 5

VisuCon-F Low Fibrinogen Control Plasma - 10629009031258 Catalog Number :

Device Description : Assayed control plasma prepared from de-fibrinated human plasma intended for use Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

VisuCon-F Low Fibrinogen Control Plasma - 10629009031814 Catalog Number :

Device Description : Assayed control plasma prepared from de-fibrinated human plasma intended for use Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 81

Visu-Cal F Frozen Calibrator Plasma - 10629009041059 Catalog Number :

Device Description : Intended for use in the calibration of coagulation and fibrinolysis assays.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 5

VisuCal-F Frozen Calibrator Plasma - 10629009041257 Catalog Number :

Device Description : Intended for use in the calibration of coagulation and fibrinolysis assays.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : JIX

Prescription Use : No

Device Count : 25

VisuCon-F Frozen Calibrator Plasma - 10629009051058 Catalog Number :

Device Description : Intended for use in the quality control of coagulation assays in the normal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 5

VisuCon-F Frozen Normal Control Plasma - 10629009051256 Catalog Number :

Device Description : Intended for use in the quality control of coagulation assays in the normal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

VisuCon-F Frozen Abnormal Control Plasma - 10629009061057 Catalog Number :

Device Description : Intended for use in the quality control of coagulation assays in the borderline Intended for use in the quality control of coagulation assays in the borderline pathological range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 5

Affinity Biologicals Inc

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