Product code MJM— Microbiology
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
- Classification name
- Dna Probe, Gardnerella Vaginalis
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MJM
FDA has cleared devices under product code MJM between 1992 and 1997, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1997
- 1992
Top applicants under product code MJM
Recent clearances under product code MJM
Data sourced from openFDA. This site is unofficial and independent of the FDA.