Affinity Biologicals Inc

Address:1348 SANDHILL DRIVE,ANCASTER Ontario,CA

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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

Plasma, Coagulation Control (GGN) (10)

Premarket Exempt

No Yes

Clear

VisuCon-F Frozen Abnormal Control Plasma - 10629009061255 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 : 25

VisuCon-F Frozen Coag Screen N - 10629009071254 Catalog Number :

Device Description : Intended for the use in quality control of quantitative coagulation assays, incl Intended for the use in quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

VisuCon-F Frozen Coag Screen N - 10629009071810 Catalog Number :

Device Description : Intended for the use in the quality control of quantitative coagulation assays, Intended for the use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 81

VisuCon-F Frozen Coag Screen N - 10629009074811 Catalog Number :

Device Description : Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 81

VisuCon-F Frozen Coag Screen ABN - 10629009081253 Catalog Number :

Device Description : Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

VisuCon-F Frozen Coag Screen ABN - 10629009081819 Catalog Number :

Device Description : Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 81

VisuCon-F Frozen Coag Screen ABN - 10629009084810 Catalog Number :

Device Description : Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) in the mid-level abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 81

VisuCon-L Coag Screen N Plasma - 10629009091108 Catalog Number :

Device Description : A pool of normal citrated human plasma collected from a minimum of 20 donors, bu A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

VisuCon-L Coag Screen ABN1 Plasma - 10629009101104 Catalog Number :

Device Description : A pool of citrated human plasma collected from a minimum of 20 donors that has b A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

VisuCon-L Coag Screen ABN2 Plasma - 10629009111103 Catalog Number :

Device Description : A pool of citrated human plasma collected from a minimum of 20 donors that has b A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the highly abnormal range.

Device Class :

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

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