Affinity Biologicals Inc

Address:1348 SANDHILL DRIVE,ANCASTER Ontario,CA

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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

Plasma, Coagulation Control (GGN) (2) Reagents, Specific, Analyte (MVU) (2)

Premarket Exempt

No Yes

Clear

VisuCon-L(TM) Abnormal Control Plasma - 10629009121102 Catalog Number :

Device Description : A pool of citrated normal human plasma collected from a minimum of 20 donors, an A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.

Device Class :

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

VisuCon-L(TM) Normal Control Plasma - 10629009131101 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 and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.

Device Class :

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : No

Device Count : 10

Sheep anti-human Factor XIII Analyte Specific Reagent - 10629009140516 Catalog Number :

Device Description : The specific use of this ASR (Analyte Specific Reagent) will depend upon the end The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application.

Device Class : 1

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Sheep anti-human Factor XIII Analyte Specific Reagent - 10629009145016 Catalog Number :

Device Class : 1

Duns Number: 249373515

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

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