Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
SEA is the FDA product code for Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users, a class II device type, regulated under 21 CFR 866.3386. FDA's definition for this code reads: "This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SEA
- Device name
- Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- FDA definition
- This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.
- Regulation
- 21 CFR 866.3386
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SEA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SEA| Applicant | Clearances |
|---|---|
| Visby Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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