Product code MCS— Microbiology

ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.

Classification name
Dna-Probe, Staphylococcus Aureus
Device class
Class 1
Regulation
21 CFR 866.3700
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code MCS

FDA has cleared 1 device under product code MCS, all in 1990, 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 MCS

Recent clearances under product code MCS

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