Biomedica ADI Inc.

Biomedica ADI Inc.

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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

REAGENT, RUSSEL VIPER VENOM (GIR) (3) TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY (GGP) (3) ASSAY, HEPARIN (KFF) (2) ANTITHROMBIN III QUANTITATION (JBQ) (1) TEST, TIME, PROTHROMBIN (GJS) (1)

Premarket Exempt

No

Clear

DVVtest 10 - 00850201006017 Catalog Number : 810

Device Class :

Duns Number: 080600606

Premarket Exempt : No

Product Code : GIR

Prescription Use : Yes

Device Count : 10

DVVconfirm 5 - 00850201006024 Catalog Number : 815

Device Class :

Duns Number: 080600606

Premarket Exempt : No

Product Code : GIR

Prescription Use : Yes

Device Count : 10

ACTICHROME Heparin (Anti-FIIa) - 00850201006031 Catalog Number : 820

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : KFF

Prescription Use : Yes

Device Count : 1

IMUBIND PLASMA PAI-1 ELISA - 00850201006048 Catalog Number : 822

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

ACTICLOT dPT - 00850201006055 Catalog Number : 824

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

DVVtest 25 - 00850201006062 Catalog Number : 825

Device Class :

Duns Number: 080600606

Premarket Exempt : No

Product Code : GIR

Prescription Use : Yes

Device Count : 10

ACTICHROME HEPARIN (ANTI-FXA) - 00850201006079 Catalog Number : 832

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : KFF

Prescription Use : Yes

Device Count : 1

ACTICHROME ATIII KIT - 00850201006086 Catalog Number : 838

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : JBQ

Prescription Use : Yes

Device Count : 1

IMUBIND vWF ACTIVITY ELISA - 00850201006093 Catalog Number : 885

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

SPECTROLYSE PAI-1 - 00850201006109 Catalog Number : 101201

Device Class : 2

Duns Number: 080600606

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

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