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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 1 of 4

Device	Model / Reference	Registries	Class	Status
K-ASSAY® Hemoglobin A1c Control	K29C-4M	FDA UDI	Class II	Active
K-ASSAY® ASO/RF/CRP Control	K55C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Factor XIII Control	K135C-10M	FDA UDI	Class I	Active
K-ASSAY® Prealbumin Calibrator	KAI-054C	FDA UDI	Class I	Active
K-ASSAY® RF Calibrator (Ver.2)	KAI-400C	FDA UDI	Class II	Active
K-ASSAY® Insulin Calibrator	KAI-072C	FDA UDI	Class I	Active
K-ASSAY® Insulin Control	K73C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Cystatin C Reagent (L)	KAI-074	FDA UDI	Class II	Active
K-ASSAY® Total IgE Control	K94C-4M	FDA UDI	Class I	Unknown
K-ASSAY® Factor XIII Control	K204C-10M	FDA UDI	Class I	Unknown
K-ASSAY® Apo B Reagent	KAI-004	FDA UDI	Class II	Active
K-ASSAY® Fibrinogen Reagent + Calibrator	KAI-035	FDA UDI	Class II	Unknown
K-ASSAY® RF Calibrator (Ver.2)	KAI-231C	FDA UDI	Class II	Active
K-ASSAY® Apo B Reagent (L)	KAI-024	FDA UDI	Class II	Unknown
K-ASSAY® Complement C4 Reagent	KAI-010	FDA UDI	Class II	Active
K-ASSAY® Lp(a) Control	K114C-2M	FDA UDI	Class II	Unknown
K-ASSAY® Alpha-1 AG Reagent	KAI-021	FDA UDI	Class I	Unknown
K-ASSAY® Urine Alpha-1 Microglobulin Calibrator	KAI-067C	FDA UDI	Class I	Active
K-ASSAY® Alpha-1 AT Reagent	KAI-001	FDA UDI	Class II	Unknown
K-ASSAY® RF Reagent (Ver.2)	KAI-230	FDA UDI	Class II	Active
K-ASSAY® Multi-Analyte Calibrator	KAI-016C	FDA UDI	Class II	Active
K-ASSAY® Hemoglobin A1c Calibrator	KAI-098C	FDA UDI	Class II	Active
K-ASSAY® D-Dimer Control	K92C-4M	FDA UDI	Class II	Active
K-ASSAY® RF / ASO Liquid Control	K125C-4M	FDA UDI	Class I	Unknown
K-ASSAY® Total IgE Calibrator	KAI-093C	FDA UDI	Class II	Unknown
K-ASSAY® ASO/RF/CRP Control	K55C-4M	FDA UDI	Class I	Active
K-ASSAY® CRP Calibrator	KAI-012C	FDA UDI	Class II	Active
K-ASSAY® ASO (WHO) Calibrator	KAI-079C	FDA UDI	Class I	Active
K-ASSAY® Fibrinogen Control	K63C-10M	FDA UDI	Class II	Active
K-ASSAY® Insulin Reagent (L)	KAI-071	FDA UDI	Class I	Active
K-ASSAY® Apo AI Reagent	KAI-002	EUDAMEDFDA UDI	Class II	Active
K-ASSAY® IgG Reagent	KAI-014	FDA UDI	Class II	Active
K-ASSAY® Factor XIII Reagent	KAI-105	FDA UDI	Class I	Active
K-ASSAY® Beta-2 Microglobulin Urine Control	K284C-4M	FDA UDI	Class I	Unknown
K-ASSAY® Ferritin Reagent	KAI-095	FDA UDI	Class II	Active
K-ASSAY® Fructosamine Reagent + Calibrator (L)	KAI-050	FDA UDI	Class II	Unknown
K-ASSAY® UIBC Calibrator	KAI-302C	FDA UDI	Class I	Active
K-ASSAY® Apo AI / B Control	K310C-4M	FDA UDI	Class I	Active
K-ASSAY® Total IgE Control	K94C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Ferritin Reagent (L)	KAI-046	FDA UDI	Class II	Unknown
K-ASSAY® Liquid ITA Control	K49C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Fructosamine Calibrator	KAI-048C	FDA UDI	Class II	Unknown
K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control	K283C-2M	FDA UDI	Class I	Unknown
K-ASSAY® Ferritin / IgE / Insulin Control, L3	K59C-L3	FDA UDI	Class I	Unknown
K-ASSAY® Fibrinogen Calibrator	KAI-089C	FDA UDI	Class II	Unknown
K-ASSAY® Lp(a) Control	K114C-4M	FDA UDI	Class II	Active
K-ASSAY® ASO (WHO) Reagent	KAI-078	FDA UDI	Class I	Active
K-ASSAY® Apo AI/B Calibrator	KAI-008C	FDA UDI	Class II	Active
K-ASSAY® Cystatin C Control	K100C-4M	FDA UDI	Class I	Active
K-ASSAY® Ferritin / IgE / Insulin Control, L1	K59C-L1	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

Advena Limited MT

Importers

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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