Is this your brand? Sign in to claim ownership.

KAMIYA BIOMEDICAL COMPANY, LLC

United States·US-MF-000002769

Last updated May 24, 2026

What KAMIYA BIOMEDICAL COMPANY, LLC makes

KAMIYA BIOMEDICAL COMPANY, LLC manufactures in vitro diagnostic (IVD) products including reagents, calibrators, and controls for various biomarkers such as C-reactive protein (CRP), plasma proteins, microalbumin, glycated hemoglobin (HbA1c), and Beta-2-microglobulin. Their product portfolio includes specific devices like the K-ASSAY® Hemoglobin A1c Control, K-ASSAY® Prealbumin Calibrator, and K-ASSAY® Cystatin C Reagent (L), among others.

The company's devices are regulated and listed in multiple registries including EUDAMED, FDA 510(k), and FDA UDI, with device classes ranging from Class I to Class II. KAMIYA BIOMEDICAL COMPANY, LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does KAMIYA BIOMEDICAL COMPANY, LLC manufacture?

Where is KAMIYA BIOMEDICAL COMPANY, LLC based?

KAMIYA BIOMEDICAL COMPANY, LLC is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list KAMIYA BIOMEDICAL COMPANY, LLC's devices?

The company's devices are listed in multiple regulatory registries including EUDAMED, FDA 510(k), and FDA UDI, as specified in the device data.

How are KAMIYA BIOMEDICAL COMPANY, LLC's devices classified?

The company's devices are classified under different regulatory classes ranging from Class I to Class II, with Class B also mentioned, as indicated in the device data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 12779 Gateway Drive S., Tukwila, WA, United States
Website: www.k-assay.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 206-575-8068
PRRC Contact: Colin Getty
EUDAMED SRN: US-MF-000002769
FDA FEI Number: —
DUNS Number: 197934250

Catalogue (162)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
K-ASSAY® Microalbumin Calibrator	KAI-020C	FDA UDI	Class II	Active
K-ASSAY® Fructosamine Reagent + Calibrator	KAI-043	FDA UDI	Class II	Unknown
K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control	K283C-4M	FDA UDI	Class I	Active
K-ASSAY® Apo AI / B Control	K310C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Transferrin Reagent	KAI-023	FDA UDI	Class II	Active
K-ASSAY® Haptoglobin Reagent	KAI-022	FDA UDI	Class II	Active
K-ASSAY® CRP (3) Calibrator D	KAI-083C	FDA UDI	Class II	Unknown
K-ASSAY® Ferritin / IgE / Insulin Control	K59C-3M	FDA UDI	Class I	Unknown
K-ASSAY® Fructosamine Control	K52C-6M	FDA UDI	Class I	Unknown
K-ASSAY® Beta-2 Microglobulin Reagent	KAI-280	FDA UDI	Class II	Active
K-ASSAY® UIBC Reagent (L)	KAI-301	FDA UDI	Class I	Unknown
K-ASSAY® Hemoglobin A1c Reagent	KAI-196	FDA UDI	Class II	Active
K-ASSAY® Lp(a) Reagent (L)	KAI-017	FDA UDI	Class II	Unknown
K-ASSAY® Cystatin C Control	K100C-2M	FDA UDI	Class I	Unknown
K-ASSAY® RF / ASO Liquid Control	K125C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Factor XIII Calibrator	KAI-106C	FDA UDI	Class I	Active
K-ASSAY® D-Dimer Reagent	KAI-090	FDA UDI	Class II	Active
K-ASSAY® Microalbumin Urine Control	K37C-4M	FDA UDI	Class I	Active
K-ASSAY® Coagulation Control	K104C-10M	FDA UDI	Class I	Active
K-ASSAY® Beta-2 Microglobulin Urine Calibrator	KAI-282C	FDA UDI	Class II	Active
K-ASSAY® Cystatin C Calibrator	KAI-099C	EUDAMEDFDA UDI	Class II	Active
K-ASSAY® Insulin Control	K73C-4M	FDA UDI	Class I	Active
K-ASSAY® Liquid ITA Control	K49C-4M	FDA UDI	Class I	Active
K-ASSAY® CRP (3) Calibrator E	KAI-084C	FDA UDI	Class II	Active
K-ASSAY® hsCRP Control	K180C-2M	FDA UDI	Class I	Active
K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator	KAI-281C	FDA UDI	Class II	Active
K-ASSAY® CRP (3) Reagent	KAI-082	FDA UDI	Class II	Active
K-ASSAY® Lp(a) Calibrator	KAI-018C	FDA UDI	Class II	Active
K-ASSAY® CRP Reagent (L)	KAI-033	FDA UDI	Class II	Unknown
K-ASSAY® hs-CRP Control	K80C-4M	FDA UDI	Class II	Unknown
K-ASSAY® Microalbumin Reagent (L)	KAI-057	FDA UDI	Class II	Active
K-ASSAY® D-Dimer Control	K92C-2M	FDA UDI	Class II	Unknown
K-ASSAY® Hemoglobin A1c Reagent (L)	KAI-197	FDA UDI	Class II	Active
K-ASSAY® Microalbumin Reagent	KAI-019	FDA UDI	Class II	Active
K-ASSAY® UIBC Reagent	KAI-300	FDA UDI	Class I	Active
K-ASSAY® hsCRP Reagent	KAI-160	FDA UDI	Class II	Active
K-ASSAY® D-Dimer Calibrator	KAI-091C	FDA UDI	Class II	Active
K-ASSAY® RF Calibrator	KAI-032C	FDA UDI	Class II	Unknown
K-ASSAY® Total IgE Reagent	KAI-092	FDA UDI	Class II	Unknown
K-ASSAY® Ferritin Calibrator	KAI-094C	FDA UDI	Class II	Active
K-ASSAY® RF Reagent	KAI-031	FDA UDI	Class II	Unknown
K-ASSAY® Hemoglobin A1c Hemolysis Reagent	KAI-195	FDA UDI	Class II	Unknown
K-ASSAY® Cystatin C Reagent	KAI-073	FDA UDI	Class II	Unknown
K-ASSAY® IgA Reagent	KAI-013	FDA UDI	Class II	Active
K-ASSAY® Plasma Control	K81C-6M	FDA UDI	Class II	Unknown
K-ASSAY® hsCRP Calibrator	KAI-161C	FDA UDI	Class II	Active
K-ASSAY® Fibrinogen Reagent	KAI-135	FDA UDI	Class II	Active
K-ASSAY® CRP (3) Calibrator F	KAI-086C	FDA UDI	Class II	Unknown
K-ASSAY® Beta-2 Microglobulin Urine Control	K284C-2M	FDA UDI	Class I	Active
K-ASSAY® Transferrin Reagent (L)	KAI-101	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Kamiya Biomedical Company, LLC has six recall records initiated between March 29, 2004, and September 28, 2022, with statuses including open, classified, and terminated. The reasons cited involve inconsistencies in assay results, potential long-term stability issues with specific reagents, incorrect vial contents, inaccurate calibrator values in package inserts, and mismatches in reagent performance standardization.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 28, 2022	Z-0271-2023	—	open, classified	IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Jul 19, 2017	Z-3138-2017	—	terminated	The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
May 1, 2009	Z-0973-2010	—	terminated	The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
Sep 17, 2008	Z-0923-2011	—	terminated	Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
Apr 11, 2006	Z-0850-06	—	terminated	Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent
Mar 29, 2004	Z-0940-04	—	terminated	Assay result not consistent with the assigned control value