Product code MDF— Microbiology

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

Classification name
Dna-Probe, Reagents, Coccidioides Immitis
Device class
Class 2
Regulation
21 CFR 866.3135
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code MDF

FDA has cleared 1 device under product code MDF, 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 MDF

Recent clearances under product code MDF

Data sourced from openFDA. This site is unofficial and independent of the FDA.