FDA product code LIR: Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
LIR is the FDA product code for antigen, enzyme linked immunoabsorbent assay, neisseria gonorrhoeae. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under LIR, from 3 different applicants. The average 510(k) review took 81 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae |
| Device class | Class II |
| Regulation | 21 CFR 866.3390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LIR clearance
Top LIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thermo Biostar, Inc. | 1 | 2003-04-17 |
| Abbott Laboratories | 1 | 1988-07-12 |
| Hygeia Sciences | 1 | 1988-06-02 |
Most recent LIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023947 | Thermo Biostar, Inc. | GC OIA | 2003-04-17 | 141 |
| K882534 | Abbott Laboratories | ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL | 1988-07-12 | 21 |
| K881064 | Hygeia Sciences | HYGEIA GC TEST | 1988-06-02 | 80 |
Recalls for LIR devices
openFDA lists no recalls for product code LIR.
Frequently asked questions
What is FDA product code LIR?
LIR is the FDA product code for antigen, enzyme linked immunoabsorbent assay, neisseria gonorrhoeae. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel.
What device class is LIR?
Class II, regulation 21 CFR 866.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIR?
Across 3 cleared submissions the average was 81 days from receipt to decision (median 80).
Which companies have the most LIR clearances?
Thermo Biostar, Inc. (1); Abbott Laboratories (1); Hygeia Sciences (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LIR
- Run a recall and safety report across every LIR manufacturer
- Watch product code LIR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times