DeviceClearance

Product code PMN— Microbiology

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

Classification name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Device class
Class 2
Regulation
21 CFR 866.3920
Advisory panel
Microbiology
Total cleared
32
First cleared
Most recent

FDA classification definition

“Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.”

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

Market context for product code PMN

FDA has cleared 32 devices under product code PMN between 2016 and 2026, filed by 8 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

Top applicants under product code PMN

Recent clearances under product code PMN

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