KAMIYA BIOMEDICAL COMPANY, LLC

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

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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

C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Calibrator, Secondary (JIT) (1) Ferritin, Antigen, Antiserum, Control (DBF) (1) Fibrin Split Products (GHH) (1) Ige, Antigen, Antiserum, Control (DGC) (1) Prealbumin, Antigen, Antiserum, Control (JZJ) (1) Radioimmunoassay, Immunoreactive Insulin (CFP) (1) System, Test, Rheumatoid Factor (DHR) (1) Test, Fibrinogen (GIS) (1) Transferrin, Antigen, Antiserum, Control (DDG) (1)

Premarket Exempt

No Yes

Clear

K-ASSAY® CRP (3) Reagent - 00816426020344 Catalog Number : KAI-082

Device Description : For the quantitative determination of human C-reactive protein (CRP) in serum an For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DCK

Prescription Use : Yes

Device Count : 1

K-ASSAY® Fibrinogen Reagent (L) - 00816426020351 Catalog Number : KAI-088

Device Description : For the quantitative determination of human fibrinogen in plasma.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : GIS

Prescription Use : Yes

Device Count : 1

K-ASSAY® D-Dimer Reagent - 00816426020368 Catalog Number : KAI-090

Device Description : For the quantitative determination of human D-dimer in plasma or serum by immuno For the quantitative determination of human D-dimer in plasma or serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : GHH

Prescription Use : Yes

Device Count : 1

K-ASSAY® Total IgE Reagent - 00816426020375 Catalog Number : KAI-092

Device Description : For the quantitative determination of human total IgE in serum or plasma by immu For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DGC

Prescription Use : Yes

Device Count : 1

K-ASSAY® Transferrin Reagent (L) - 00816426020382 Catalog Number : KAI-101

Device Description : For the quantitative determination of human transferrin in serum by immunoturbid For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DDG

Prescription Use : Yes

Device Count : 1

K-ASSAY® Prealbumin Calibrator - 00816426020405 Catalog Number : KAI-054C

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

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : JZJ

Prescription Use : Yes

Device Count : 1

K-ASSAY® Insulin Calibrator - 00816426020412 Catalog Number : KAI-072C

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

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

K-ASSAY® RF Calibrator - 00816426020429 Catalog Number : KAI-032C

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

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

K-ASSAY® Microalbumin Calibrator - 00816426020443 Catalog Number : KAI-020C

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

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

K-ASSAY® Ferritin Reagent - 00816426020450 Catalog Number : KAI-095

Device Description : For the quantitative determination of human ferritin in serum and plasma by immu For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DBF

Prescription Use : Yes

Device Count : 1

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