Product code GPN— Microbiology
RICKETTSIAL IGG AND IGM IFA KIT
- Classification name
- Antiserum, Typhus Fever
- Device class
- Class 1
- Regulation
- 21 CFR 866.3500
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GPN
FDA has cleared device under product code GPN, all in 1987, 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 GPN
Recent clearances under product code GPN
Data sourced from openFDA. This site is unofficial and independent of the FDA.