ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Address:6260 Sequence Dr,San Diego,CA,92121,US

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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

Activated Whole Blood Clotting Time (JBP) (3) System, Multipurpose For In Vitro Coagulation Studies (JPA) (2) Activated Partial Thromboplastin (GFO) (1) Protamine Sulphate (GFT) (1) Test, Time, Prothrombin (GJS) (1) Plasma, Coagulation Control (GGN) (1) Assay, Heparin (KFF) (1)

Premarket Exempt

No Yes

Clear

Hemochron Whole Blood Coagulation System - 10711234101094 Catalog Number : P214

Device Description : ACT Tubes 95 tubes/box

Device Class :

Duns Number: 079299318

Premarket Exempt : Yes

Product Code : JBP

Prescription Use : Yes

Device Count : 95

Hemochron Whole Blood Coagulation System - 10711234101230 Catalog Number : PDAO

Device Description : Celite Protamine Dose Assay - 40 tubes/box

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : JPA

Prescription Use : Yes

Device Count : 40

Hemochron Whole Blood Coagulation System - 10711234101384 Catalog Number : HRFTCA510

Device Description : Celite ACT Tubes - 95 tubes/box

Device Class :

Duns Number: 079299318

Premarket Exempt : Yes

Product Code : JBP

Prescription Use : Yes

Device Count : 95

Hemochron Whole Blood Coagulation System - 10711234101391 Catalog Number : HRFTK-ACT

Device Description : Kaolin ACT Tubes - 95 tubes/box

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : JBP

Prescription Use : Yes

Device Count : 95

Hemochron Whole Blood Coagulation System - 10711234102176 Catalog Number : RQCHRT

Device Description : RxDx Whole Blood Quality Control Heparin 40/box

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : KFF

Prescription Use : Yes

Device Count : 40

Hemochron Whole Blood Coagulation System - 10711234102183 Catalog Number : RQCPRT

Device Description : RxDx Whole Blood Quality Control Protamine 40/box

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : GFT

Prescription Use : Yes

Device Count : 40

Hemochron Whole Blood Coagulation System - 10711234102206 Catalog Number : QCACT

Device Description : ACT Whole Blood Quality Control 40/box

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 40

Hemochron Whole Blood Microcoagulation System - 10711234103012 Catalog Number : J103

Device Description : APTT Cuvette - 45 test cuvettes/box

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : JPA

Prescription Use : Yes

Device Count : 45

Hemochron Whole Blood Microcoagulation System - 10711234103029 Catalog Number : J103C

Device Description : Citrate APTT Cuvette - 45 test cuvettes/box.

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 45

Hemochron Whole Blood Microcoagulation System - 10711234103036 Catalog Number : J201

Device Description : PT Cuvette - 45 test cuvettes/box.

Device Class :

Duns Number: 079299318

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 45

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