Identifiers
- 510(k) Number
- K863717 FDA 510(k)
- FDA Product Code
- DHN 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)
The Anti-DNA Microassay is a Class II medical device classified as an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control. It is designed for use in immunology testing to detect anti-DNA antibodies in patient samples.
This device is supplied by Diamedix Corp. and is regulated under FDA 510(k) clearance with product code DHN. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Anti-DNA Microassay used for?
The Anti-DNA Microassay is designed for immunology testing to detect anti-DNA antibodies in patient samples. It is classified as an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control device.
How is the Anti-DNA Microassay supplied?
The Anti-DNA Microassay is supplied by Diamedix Corp. The device data does not specify whether it is single-use or reusable, nor does it provide information about sterility or storage conditions.
What is the regulatory status of the Anti-DNA Microassay?
The Anti-DNA Microassay is regulated under FDA 510(k) clearance with product code DHN. It has been determined to be substantially equivalent to other devices in its class.
What sizes or models of the Anti-DNA Microassay are available?
The device data does not specify different sizes or models for the Anti-DNA Microassay. It is described as a single device type for detecting anti-DNA antibodies in immunology testing.
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. Sources consulted: ANTI-DNA MICROASSAY (K863717) — FDA 510 (k) | Innolitics, ANTI-DNA MICROASSAY 510 (k) K863717 - FDA.report, K872560 FDA 510 (k) - ANTI-DNP MICROASSAY | Diamedix Corp., PDF K912020 - Anti-dna Microassay, Diamedix Corp. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K863717 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA 510(k) K863717 24 fields · synced Sep 24, 2026