FDA product code LTS: Test Reagents, Neisseria Gonorrhoeae Biochemical
LTS is the FDA product code for test reagents, neisseria gonorrhoeae biochemical. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under LTS. The average 510(k) review took 105 days (median 105). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Test Reagents, Neisseria Gonorrhoeae Biochemical |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LTS clearance
Top LTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Difco Laboratories, Inc. | 1 | 1996-01-30 |
Most recent LTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954784 | Difco Laboratories, Inc. | DRYSIDE NEISSERIA | 1996-01-30 | 105 |
Recalls for LTS devices
openFDA lists no recalls for product code LTS.
Frequently asked questions
What is FDA product code LTS?
LTS is the FDA product code for test reagents, neisseria gonorrhoeae biochemical. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is LTS?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LTS?
Across 1 cleared submissions the average was 105 days from receipt to decision (median 105).
Which companies have the most LTS clearances?
Difco Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LTS
- Run a recall and safety report across every LTS manufacturer
- Watch product code LTS 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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