Bio/Data Corporation

Bio/Data Corporation

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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

System, Automated Platelet Aggregation (JOZ) (7) Test, Qualitative And Quantitative Factor Deficiency (GGP) (3)

Premarket Exempt

No

Clear

AggRecetin - G0561009700 Catalog Number : 100970

Device Description : Ristocetin Sulphate

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

AggRecetin - G0561012410 Catalog Number : 101241

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

Lyophilized Platelets - G0561012580 Catalog Number : 101258

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

vW Normal Reference Plasma - G0561012691 Catalog Number : 101269

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

vW Abnormal Control Plasma - G0561012701 Catalog Number : 101270

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

Arachidonic Acid - G0561012971 Catalog Number : 101297

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

PAR/PAK II - G0561013101 Catalog Number : 101310

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

Epinephrine - G0561013111 Catalog Number : 101311

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

ADP - G0561013121 Catalog Number : 101312

Device Description : Adenosine-5'-Diphosphate

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

Collagen - G0561015621 Catalog Number : 101562

Device Class : 2

Duns Number: 051392959

Premarket Exempt : No

Product Code : JOZ

Prescription Use : Yes

Device Count : 1

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