Product code GQT— Microbiology

GOAT ANTI-INFLUENZA ANTISERA

Classification name: Antisera, Cf, Parainfluenza Virus 1-4
Device class: Class 1
Regulation: 21 CFR 866.3400
Advisory panel: Microbiology
Total cleared: 4
First cleared: 1978-01-20
Most recent: 1987-09-18

Market context for product code GQT

FDA has cleared 4 devices under product code GQT between 1978 and 1987, 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

19873 clearances
19781 clearance

Top applicants under product code GQT

Sita, Inc.3 clearances
Northeast Biomedical Labs., Inc.1 clearance

Recent clearances under product code GQT

K872695 — PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.·1987-09-18
K872696 — PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.·1987-09-18
K872697 — PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.·1987-09-18
K780008 — GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.·1978-01-20

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