Antinuclear Antibody (ANA) Screening Test Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K914853 FDA 510(k)
- FDA Product Code
- LJM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An Antinuclear Antibody (ANA) Screening Test Kit is a diagnostic device used to detect antinuclear antibodies in human serum. It is classified as a Class II medical device under regulation number 866.5100 and is substantially equivalent to a legally marketed predicate device.
The kit is intended for use in immunology laboratories and includes enzyme-labeled antigen and controls. It is supplied as a test kit for in vitro diagnostic use and has received FDA 510(k) clearance under K914853. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety, storage conditions, or size specifications are included.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914853 | Class II | Active |
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Manufacturer
- Manufacturer
- Reads Medical Products, Inc.
Sources (1)
- FDA 510(k) K914853 24 fields · synced Sep 21, 2026