FDA product code LRF: Candida Spp., Direct Antigen, Id
LRF is the FDA product code for candida spp., direct antigen, id. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under LRF, from 3 different applicants. The average 510(k) review took 100 days (median 67). FDA has posted 2 recalls for LRF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Candida Spp., Direct Antigen, Id |
| Device class | Class II |
| Regulation | 21 CFR 866.3165 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LRF clearance
Top LRF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medi-Tech, Inc. | 1 | 1988-09-30 |
| Mercia Diagnostics , Ltd. | 1 | 1987-03-19 |
| Immuno-Mycologics, Inc. | 1 | 1984-10-01 |
Most recent LRF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883118 | Medi-Tech, Inc. | ON THE SPOT CANDIDASURE | 1988-09-30 | 67 |
| K863499 | Mercia Diagnostics , Ltd. | CANDIDATE(R) SUPER | 1987-03-19 | 191 |
| K843286 | Immuno-Mycologics, Inc. | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | 1984-10-01 | 41 |
Recalls for LRF devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LRF?
LRF is the FDA product code for candida spp., direct antigen, id. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is LRF?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRF?
Across 3 cleared submissions the average was 100 days from receipt to decision (median 67).
Which companies have the most LRF clearances?
Medi-Tech, Inc. (1); Mercia Diagnostics , Ltd. (1); Immuno-Mycologics, Inc. (1).
Have LRF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LRF
- Run a recall and safety report across every LRF manufacturer
- Watch product code LRF 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.
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