DeviceClearance

Product code GQP— Microbiology

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3

Classification name
Antisera, Neutralization, Parainfluenza Virus 1-4
Device class
Class 1
Regulation
21 CFR 866.3400
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GQP

FDA has cleared 2 devices under product code GQP between 1994 and 1998, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code GQP

Recent clearances under product code GQP

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