Product code MDE— Microbiology
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST
- Classification name
- Dna-Probe, Reagents, Cryptococcal
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code MDE
FDA has cleared device under product code MDE, all in 1990, 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 MDE
Recent clearances under product code MDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.