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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 3 of 4

Device	Model / Reference	Registries	Class	Status
K-ASSAY® Insulin Reagent	KAI-040	FDA UDI	Class I	Unknown
K-ASSAY® Liquid Lipid Control	K110C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Alpha-1 Microglobulin Reagent	KAI-056	FDA UDI	Class I	Active
K-ASSAY® Lp(a) Reagent	KAI-044	FDA UDI	Class II	Active
K-ASSAY® Microalbumin Urine Control	K37C-SAM	FDA UDI	Class I	Unknown
K-ASSAY® IgM Reagent	KAI-015	FDA UDI	Class II	Active
K-ASSAY® Prealbumin Reagent	KAI-053	FDA UDI	Class I	Active
K-ASSAY® CRP Reagent	KAI-026	FDA UDI	Class II	Active
K-ASSAY® Fibrinogen Reagent (L)	KAI-088	FDA UDI	Class II	Unknown
K-ASSAY® Ferritin / IgE / Insulin Control, L2	K59C-L2	FDA UDI	Class I	Unknown
K-ASSAY® Fibrinogen Calibrator	KAI-136C	FDA UDI	Class II	Active
K-ASSAY® Complement C3 Reagent	KAI-009	FDA UDI	Class II	Active
K-ASSAY® Serum / Plasma Alpha-1 Microglobulin Calibrator	KAI-068C	FDA UDI	Class I	Active
K-ASSAY CRP (Ver.2)	K242170	FDA 510(k)	Class II	Active
K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator	K992976	FDA 510(k)	Class II	Active
Liquid Immunology Controls For Immunoturbidimetric Assays	K983130	FDA 510(k)	Class I	Active
K-Assay Rheumatoid Factor	K991409	FDA 510(k)	Class II	Active
K-Assay Fibrinogen	K993482	FDA 510(k)	Class II	Active
K-Assay Apo B	K993354	FDA 510(k)	Class II	Active
K-Assay Haptoglobin	K993480	FDA 510(k)	Class II	Active
K-Assay Alpha-1 Ag	K993441	FDA 510(k)	Class I	Active
K-Assay Lp(a) Assay	K021660	FDA 510(k)	Class II	Active
Rf Control For Immunoturbidimetric Assays	K984045	FDA 510(k)	Class II	Active
K-Assay Lp(a) Controls	K023853	FDA 510(k)	Class II	Active
K-Assay Microalbumin Calibrator Set	K991166	FDA 510(k)	Class II	Active
K-Assay Ferritin (2) & Ferritin Calibrator Set	K050944	FDA 510(k)	Class II	Active
K-Assay Apo Ai	K993345	FDA 510(k)	Class II	Active
K-Assay D-Dimer With Calibrator Set And Calibrator Diluent	K002948	FDA 510(k)	Class II	Active
K-Assay Iga	K993213	FDA 510(k)	Class II	Active
K-Assay Crp (2), K-Assay Crp Multi-Calibrator A, K-Assay Crp Multi-Calibrator B	K992312	FDA 510(k)	Class II	Active
K-Assay Alpha-1 At	K993444	FDA 510(k)	Class II	Active
K-Assay Cystatin C Reagent, Calibrator And Control	K093137	FDA 510(k)	Class II	Active
K-Assay Rheumatoid Factor Calibrator Set	K991467	FDA 510(k)	Class II	Active
Direct Hdl-Cholesterol Reagent	K990581	FDA 510(k)	Class I	Active
K-Assay Crp	K991224	FDA 510(k)	Class II	Active
K-Assay Igg	K993281	FDA 510(k)	Class II	Active
K-Assay Crp(1), K-Assay Crp Multi-Calibrator A, K-Assay Crp Multi-Calibratorc	K992311	FDA 510(k)	Class II	Active
K-Assay D-Dimer Controls	K012422	FDA 510(k)	Class II	Active
K-Assay High Sensitive Crp(2) For The Beckman Coulter Immage	K002558	FDA 510(k)	Class II	Active
K-Assay Transferrin	K993537	FDA 510(k)	Class II	Active
K-Assay C3	K993437	FDA 510(k)	Class II	Active
K-Assay Microalbumin And K-Assay Microalbumin Calibrator	K091486	FDA 510(k)	Class II	Active
K-Assay C1-Ina	K011780	FDA 510(k)	Class II	Active
K-Assay Igm	K993323	FDA 510(k)	Class II	Active
K-Assay At-Iii	K000361	FDA 510(k)	Class II	Active
K-Assay Hs-Crp Controls	K022486	FDA 510(k)	Class II	Active
K-Assay Ferritin, K-Assay Ferritin Calibrator Set	K014293	FDA 510(k)	Class II	Active
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)	K192727	FDA 510(k)	Class II	Active
K-Assay Apo A1/B Calibrator Set	K993606	FDA 510(k)	Class II	Active
K-Assay Crp Calibrator Set	K991210	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

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Notified Bodies

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Authorities

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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