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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?
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.
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/
- —
- —
- [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 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| K-Assay Total Ige, K-Assay Ige Calibrator Set, Models Kai-092/Kai-093c | K042241 | FDA 510(k) | Class II | Active |
| K-Assay C-Reactive Protein (3), K-Assay Crp Multi-Calibrator D, K-Assay Crp Multi-Calibrator E, K-Assay Crp Multi-Calibr | K023828 | FDA 510(k) | Class II | Active |
| K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models Kai-090; Kaj-091c | K030687 | FDA 510(k) | Class II | Active |
| K-Assay Multi-Analyte Calibrator | K993853 | FDA 510(k) | Class II | Active |
| K-Assay C4 | K993481 | FDA 510(k) | Class II | Active |
| Aso/Crp/Rf Controls For Immunoturbidimetric Assays | K983241 | FDA 510(k) | Class I | Active |
| K-Assay (r) Ferritin Reagent, K-Assay (r) Ferritin Calibrator | K121232 | FDA 510(k) | Class II | Active |
| Determiner Pl/Determination Of Phospholipids | K905829 | FDA 510(k) | Class I | Active |
| K-Assay Hs-Crp Controls | K011079 | FDA 510(k) | Class II | Active |
| Factor XIII | KAI-205 | EUDAMEDFDA UDI | Class B | Active |
| Factor XIII Calibrator | KAI-206C | EUDAMEDFDA UDI | Class B | Active |
| Coagulation Control | K204C-10M | EUDAMEDFDA UDI | Class B | Active |
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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 |