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) (8) Control, Plasma, Abnormal (GGC) (4) Plasma, Control, Normal (GIZ) (2)

Premarket Exempt

No Yes

Clear

CRYOcheck™ Pooled Normal Plasma - 00843876000015 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 80

CRYOcheck™ Pooled Normal Plasma - 00843876000022 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 80

CRYOcheck™ Pooled Normal Plasma - 00843876000039 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 10

CRYOcheck™ Pooled Normal Plasma - 00843876000046 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 81

CRYOcheck™ Reference Control Normal - 00843876000053 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIZ

Prescription Use : No

Device Count : 25

CRYOcheck™ Reference Control Normal - 00843876000060 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GIZ

Prescription Use : No

Device Count : 25

CRYOcheck™ Abnormal 1 Reference Control - 00843876000077 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : No

Device Count : 25

CRYOcheck™ Abnormal 1 Reference Control - 00843876000084 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : No

Device Count : 25

CRYOcheck™ Abnormal 2 Reference Control - 00843876000091 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGC, GGN

Prescription Use : No

Device Count : 25

CRYOcheck™ Abnormal 1 Control - 00843876000107 Catalog Number :

Device Class :

Duns Number: 244713368

Premarket Exempt : No

Product Code : GGC, GGN

Prescription Use : No

Device Count : 80

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