Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
An enzyme-linked immunosorbent assay (ELISA) antigen test for Neisseria gonorrhoeae is a laboratory diagnostic test that uses an ELISA format to detect gonorrhea-specific antigens in clinical specimens, providing a non-culture approach to diagnosing gonorrheal infection in the microbiology laboratory. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LIR and is regulated under 21 CFR 866.3390 within the Microbiology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LIR
- Device Class
- FDA class 2
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023947 | GC OIA | Apr 17, 2003 | Substantially Equivalent | Thermo Biostar, Inc. |
| K882534 | ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL | Jul 12, 1988 | Substantially Equivalent | Abbott Laboratories |
| K881064 | HYGEIA GC TEST | Jun 02, 1988 | Substantially Equivalent | Hygeia Sciences |