Devices

Device Recall IVD calibrator

Model / Serial
Catalog number: "KAI-084C", Lot # "559011"
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
United States (NY, NJ, and NC).
Product Description
"K-ASSAY CRP (3) Calibrator E". || This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.
Manufacturer
Kamiya Biomedical Company, LLC
1 Event
- Recall of Device Recall IVD calibrator

Manufacturer

Kamiya Biomedical Company, LLC

Manufacturer Address
Kamiya Biomedical Company, LLC, 12779 Gateway Dr S, Tukwila WA 98168-3308
Manufacturer Parent Company (2017)
Kamiya Biomedical Company Llc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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