Precision Biologic Inc

Address:140 Eileen Stubbs Avenue,Dartmouth Nova Scotia,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

Reagent, Russel Viper Venom (GIR) (5) Test, Qualitative And Quantitative Factor Deficiency (GGP) (3) Activated Partial Thromboplastin (GFO) (1) Plasma, Coagulation Control (GGN) (1) Test, Time, Partial Thromboplastin (GGW) (1)

Premarket Exempt

No Yes

Clear

CRYOcheck™ Clot S™ - 00843876000428 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 5

CRYOcheck™ Platelet Lysate - 00843876000435 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGW

Prescription Use : No

Device Count : 25

CRYOcheck™ LA Check™ - 00843876000442 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIR

Prescription Use : No

Device Count : 25

CRYOcheck™ LA Check™ - 00843876000459 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIR

Prescription Use : No

Device Count : 81

CRYOcheck™ LA Check™ - 00843876000466 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIR

Prescription Use : No

Device Count : 80

CRYOcheck™ LA Check™ - 00843876000473 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIR

Prescription Use : No

Device Count : 50

CRYOcheck™ LA Sure™ - 00843876000480 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIR

Prescription Use : No

Device Count : 25

C & S Diluent - 00843876000497 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 6

CRYOcheck™ FVIII Inhibitor Kit - 00843876000503 Catalog Number :

Device Description : The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older.

Device Class : 2

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN, GGP

Prescription Use : Yes

Device Count : 1

CRYOcheck Hex LA - 00843876000510 Catalog Number : Hex LA

Device Description : CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intend CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

Device Class : 2

Duns Number: 244713368

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 1

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