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

Immunoelectrophoretic, Immunoglobulins, (G, A, M) (CFF) (2) Alpha-1-Lipoprotein, Antigen, Antiserum, Control (DER) (2) Complement C3, Antigen, Antiserum, Control (CZW) (1) Complement C4, Antigen, Antiserum, Control (DBI) (1) Igg, Antigen, Antiserum, Control (DEW) (1) Albumin, Antigen, Antiserum, Control (DCF) (1) Lipoprotein, Low-Density, Antigen, Antiserum, Control (DFC) (1) Alpha-1-Antitrypsin, Antigen, Antiserum, Control (DEM) (1)

Premarket Exempt

No Yes

Clear

K-ASSAY® Alpha-1 AT Reagent - 00816426020009 Catalog Number : KAI-001

Device Description : For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DEM

Prescription Use : Yes

Device Count : 1

K-ASSAY® Apo AI Reagent - 00816426020016 Catalog Number : KAI-002

Device Description : For the quantitative determination of human apolipoprotein AI (Apo AI) in serum For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DER

Prescription Use : Yes

Device Count : 1

K-ASSAY® Apo B Reagent - 00816426020030 Catalog Number : KAI-004

Device Description : For the quantitative determination of human apolipoprotein B (Apo B) in serum by For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DER

Prescription Use : Yes

Device Count : 1

K-ASSAY® Complement C3 Reagent - 00816426020078 Catalog Number : KAI-009

Device Description : For the quantitative determination of human 3rd complement component (Complement For the quantitative determination of human 3rd complement component (Complement C3) in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : CZW

Prescription Use : Yes

Device Count : 1

K-ASSAY® Complement C4 Reagent - 00816426020085 Catalog Number : KAI-010

Device Description : For the quantitative determination of human 4th complement component (Complement For the quantitative determination of human 4th complement component (Complement C4) in serum by immunoturbidimetric assay.

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DBI

Prescription Use : Yes

Device Count : 1

K-ASSAY® IgA Reagent - 00816426020092 Catalog Number : KAI-013

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

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : CFF

Prescription Use : Yes

Device Count : 1

K-ASSAY® IgG Reagent - 00816426020108 Catalog Number : KAI-014

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

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : DEW

Prescription Use : Yes

Device Count : 1

K-ASSAY® IgM Reagent - 00816426020115 Catalog Number : KAI-015

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

Device Class : 2

Duns Number: 197934250

Premarket Exempt : No

Product Code : CFF

Prescription Use : Yes

Device Count : 1

K-ASSAY® Lp(a) Reagent (L) - 00816426020122 Catalog Number : KAI-017

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® Microalbumin Reagent - 00816426020139 Catalog Number : KAI-019

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

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