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

Plasma, Coagulation Control (GGN) (2) Activated Partial Thromboplastin (GFO) (1) Test, Qualitative And Quantitative Factor Deficiency (GGP) (1)

Premarket Exempt

No Yes

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CRYOcheck Hex LA - 00843876000527 Catalog Number : HEXLA-7

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

CRYOcheck Lupus Negative Control - 00843876000534 Catalog Number : CCLN-10

Device Description : Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.

Device Class :

Duns Number: 244713368

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 25

CRYOcheck Lupus Negative Control - 00843876000541 Catalog Number : CCLN-05

Device Class :

Duns Number: 244713368

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 25

CRYOcheck Factor VIII Chromogenic - 00843876000558 Catalog Number : CCCF08

Device Description : CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantita CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use

Device Class : 2

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

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