Product code LIA— Microbiology
SHIGELLA SERA-CHEK
- Classification name
- Antigens, All Groups, Shigella Spp.
- Device class
- Class 2
- Regulation
- 21 CFR 866.3660
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LIA
FDA has cleared device under product code LIA, all in 1981, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code LIA
Recent clearances under product code LIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.