Product code GQM— Microbiology
COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
- Classification name
- Antisera, Neutralization, Herpesvirus Hominis
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code GQM
FDA has cleared devices under product code GQM between 1979 and 1988, 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
- 1988
- 1981
- 1979
Top applicants under product code GQM
Recent clearances under product code GQM
Data sourced from openFDA. This site is unofficial and independent of the FDA.