Product code MDU— Microbiology
ALPHA CRYPTOCOCCAL ANTIGEN EIA
- Classification name
- Antigen, Elisa, Cryptococcus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MDU
FDA has cleared devices under product code MDU between 1991 and 2012, filed by 2 applicant companies. 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.
Clearances per year
- 2012
- 1991
Top applicants under product code MDU
Recent clearances under product code MDU
Data sourced from openFDA. This site is unofficial and independent of the FDA.