Product code IGC— Pathology
INCSTAR HSV I/II IGG FAST ELISA ASSAY
- Classification name
- Formalin-Saline
- Device class
- Class 1
- Regulation
- 21 CFR 864.4010
- Advisory panel
- Pathology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code IGC
FDA has cleared devices under product code IGC, all in 1996, 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 IGC
Recent clearances under product code IGC
Data sourced from openFDA. This site is unofficial and independent of the FDA.