Product code GPT— Microbiology
DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT
- Classification name
- Antiserum, Cf, Psittacosis (Chlamydia Group)
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GPT
FDA has cleared device under product code GPT, all in 1981, 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 GPT
Recent clearances under product code GPT
Data sourced from openFDA. This site is unofficial and independent of the FDA.