LQFClass I
Dna-Reagents, Mycobacterium Spp.
21 CFR 866.3370 / Microbiology
LQF is the FDA product code for Dna-Reagents, Mycobacterium Spp., a class I device type, regulated under 21 CFR 866.3370. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- LQF
- Device name
- Dna-Reagents, Mycobacterium Spp.
- Regulation
- 21 CFR 866.3370
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 15
- Ingested recalls
- 2
Clearances, product code LQF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1987 | 2 |
| 1989 | 1 |
| 1990 | 8 |
| 1992 | 1 |
Applicants with the most clearances
Product code LQF| Applicant | Clearances |
|---|---|
| Hologic, Inc. | 13 |
| Syngene, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code LQF.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
