Product code GTH— Microbiology
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
- Classification name
- Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GTH
FDA has cleared devices under product code GTH between 1980 and 1990, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1990
- 1986
- 1980
Top applicants under product code GTH
Recent clearances under product code GTH
Data sourced from openFDA. This site is unofficial and independent of the FDA.