KAMIYA BIOMEDICAL COMPANY, LLC

Address:12779 Gateway Dr S,Tukwila,WA,98168,US

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- Catalog Number : KAI-136C

Device Description : For the calibration of the K-ASSAY® Fibrinogen assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : GIS

Prescription Use : Yes

Device Count : 1

- Catalog Number : K135C-10M

Device Description : For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : DBT

Prescription Use : Yes

Device Count : 1

- Catalog Number : K204C-10M

Device Description : For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : DBT

Prescription Use : Yes

Device Count : 1

- Catalog Number : KAI-083C

Device Description : For the calibration of the K-ASSAY® CRP (3) assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

- Catalog Number : K92C-2M

Device Description : For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : K92C-4M

Device Description : For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : KAI-280

Device Description : For the quantitative determination of human beta-2 microglobulin in serum/plasma For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : JZG

Prescription Use : Yes

Device Count : 1

- Catalog Number : KAI-281C

Device Description : For the calibration of the K-ASSAY® Beta-2 Microglobulin assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : JZG

Prescription Use : Yes

Device Count : 1

- Catalog Number : KAI-282C

Device Description : For the calibration of the K-ASSAY® Beta-2 Microglobulin assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : JZG

Prescription Use : Yes

Device Count : 1

- Catalog Number : K283C-2M

Device Description : For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1