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

Test, Cystatin C (NDY) (2) Alpha-1 Microglobulin, Antigen, Antiserum, Control (MGA) (1) Antistreptolysin - Titer/Streptolysin O Reagent (GTQ) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Albumin, Antigen, Antiserum, Control (DCF) (1) Lipoprotein, Low-Density, Antigen, Antiserum, Control (DFC) (1) Prealbumin, Antigen, Antiserum, Control (JZJ) (1) Radioimmunoassay, Immunoreactive Insulin (CFP) (1) Ferritin, Antigen, Antiserum, Control (DBF) (1)

Premarket Exempt

No Yes

Clear

K-ASSAY® Lp(a) Reagent - 00816426020245 Catalog Number : KAI-044

Device Description : For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by i For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DFC

Prescription Use : Yes

Device Count : 1

K-ASSAY® Ferritin Reagent (L) - 00816426020252 Catalog Number : KAI-046

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

K-ASSAY® Fructosamine Reagent + Calibrator (L) - 00816426020269 Catalog Number : KAI-050

Device Description : For the quantitative determination of fructosamine in serum.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

K-ASSAY® Prealbumin Reagent - 00816426020276 Catalog Number : KAI-053

Device Description : For the quantitative determination of human prealbumin in serum by immunoturbidi For the quantitative determination of human prealbumin in serum by immunoturbidimetric assay.

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : JZJ

Prescription Use : Yes

Device Count : 1

K-ASSAY® Alpha-1 Microglobulin Reagent - 00816426020283 Catalog Number : KAI-056

Device Description : For the quantitative determination of human alpha-1 microglobulin in urine, seru For the quantitative determination of human alpha-1 microglobulin in urine, serum and plasma by immunoturbidimetric assay.

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : MGA

Prescription Use : Yes

Device Count : 1

K-ASSAY® Microalbumin Reagent (L) - 00816426020290 Catalog Number : KAI-057

Device Description : For the quantitative determination of human albumin in urine by immunoturbidimet For the quantitative determination of human albumin in urine by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DCF

Prescription Use : Yes

Device Count : 1

K-ASSAY® Insulin Reagent (L) - 00816426020306 Catalog Number : KAI-071

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

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

K-ASSAY® Cystatin C Reagent - 00816426020313 Catalog Number : KAI-073

Device Description : For the quantitative determination of human cystatin C in serum, EDTA plasma, or For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : NDY

Prescription Use : Yes

Device Count : 1

K-ASSAY® Cystatin C Reagent (L) - 00816426020320 Catalog Number : KAI-074

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : NDY

Prescription Use : Yes

Device Count : 1

K-ASSAY® ASO (WHO) Reagent - 00816426020337 Catalog Number : KAI-078

Device Description : For the quantitative determination of human streptolysin O (ASO) in serum by imm For the quantitative determination of human streptolysin O (ASO) in serum by immunoturbidimetric assay.

Device Class : 1

Duns Number: 197934250

Premarket Exempt : Yes

Product Code : GTQ

Prescription Use : Yes

Device Count : 1

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