Product code GTX— Microbiology
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
- Classification name
- Antisera, Fluorescent, All Groups, Streptococcus Spp.
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GTX
FDA has cleared devices under product code GTX between 1980 and 1981, 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
- 1981
- 1980
Top applicants under product code GTX
Recent clearances under product code GTX
Data sourced from openFDA. This site is unofficial and independent of the FDA.