Precision Biologic Inc

Address:140 Eileen Stubbs Avenue,Dartmouth Nova Scotia,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) (7) Control, Plasma, Abnormal (GGC) (5) Plasma, Coagulation Factor Deficient (GJT) (1)

Premarket Exempt

No Yes

Clear

CRYOcheck™ Abnormal 2 Control - 00843876000114 Catalog Number : 00843876010113

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGC, GGN

Prescription Use : No

Device Count : 80

CRYOcheck™ Low Fibrinogen Control - 00843876000138 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 80

CRYOcheck™ Lupus Positive Control - 00843876000145 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : No

Device Count : 25

CRYOcheck™ Lupus Positive Control - 00843876000152 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : No

Device Count : 25

CRYOcheck™ Weak Lupus Positive Control - 00843876000169 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGC

Prescription Use : No

Device Count : 25

CRYOcheck™ Weak Lupus Positive Control - 00843876000176 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGC

Prescription Use : No

Device Count : 25

CRYOcheck™ APCR Positive Control - 00843876000183 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

CRYOcheck™ Normal Reference Plasma - 00843876000190 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

CRYOcheck™ Normal Reference Plasma - 00843876000206 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 25

CRYOcheck™ Factor II Deficient Plasma - 00843876000213 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GJT

Prescription Use : No

Device Count : 25

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