DeviceClearance

Product code QCH— Microbiology

Multichem ID-G (09339892190) +5 more

Classification name
Assayed Quality Control Material For Clinical Microbiology Assays
Device class
Class 2
Regulation
21 CFR 866.3920
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Serologic controls for microbiology assays”

— U.S. Food and Drug Administration, device classification record for product code QCH under 21 CFR 866.3920, via openFDA

Market context for product code QCH

FDA has cleared 1 device under product code QCH, all in 2025, 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 QCH

Recent clearances under product code QCH

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