FDA product code LQF: Dna-Reagents, Mycobacterium Spp.
LQF is the FDA product code for dna-reagents, mycobacterium spp.. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel. FDA has cleared 15 510(k) submissions under LQF, from 2 different applicants. The average 510(k) review took 129 days (median 124). FDA has posted 2 recalls for LQF devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Mycobacterium Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3370 |
| 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 LQF clearance
Top LQF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 13 | 1992-07-23 |
| Syngene, Inc. | 2 | 1990-04-03 |
Most recent LQF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921435 | Gen-Probe, Inc. | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | 1992-07-23 | 120 |
| K904463 | Gen-Probe, Inc. | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST | 1990-11-13 | 43 |
| K897077 | Gen-Probe, Inc. | ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE | 1990-08-23 | 244 |
| K896494 | Gen-Probe, Inc. | ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST | 1990-08-23 | 283 |
| K897078 | Gen-Probe, Inc. | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | 1990-05-02 | 131 |
Recalls for LQF devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-12-30.
Frequently asked questions
What is FDA product code LQF?
LQF is the FDA product code for dna-reagents, mycobacterium spp.. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel.
What device class is LQF?
Class I, regulation 21 CFR 866.3370. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQF?
Across 15 cleared submissions the average was 129 days from receipt to decision (median 124).
Which companies have the most LQF clearances?
Gen-Probe, Inc. (13); Syngene, Inc. (2).
Have LQF devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2008-12-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LQF
- Run a recall and safety report across every LQF manufacturer
- Watch product code LQF 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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