Product code GMS— Microbiology
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
- Classification name
- Anti-Human Globulin, Fta-Abs Test
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GMS
FDA has cleared devices under product code GMS between 1978 and 1985, filed by 2 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
- 1985
- 1984
- 1978
Top applicants under product code GMS
Recent clearances under product code GMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.