Product code GSH— Microbiology
AGGLUTINOTEST-LISTERIA
- Classification name
- Antisera, All Types, Listeria Monocytogenes
- Device class
- Class 1
- Regulation
- 21 CFR 866.3355
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GSH
FDA has cleared device under product code GSH, all in 1979, filed by 1 applicant company. 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.
Top applicants under product code GSH
Recent clearances under product code GSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.