Product code GNS— Microbiology

GOAT ANTI-INFLUENZA ANTISERA

Classification name: Antisera, Hai, Influenza Virus A, B, C
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Total cleared: 9
First cleared: 1978-01-20
Most recent: 1978-05-03

Market context for product code GNS

FDA has cleared 9 devices under product code GNS, all in 1978, 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.

Top applicants under product code GNS

Northeast Biomedical Labs., Inc.5 clearances
Flow Laboratories, Inc.4 clearances

Recent clearances under product code GNS

K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSRNortheast Biomedical Labs., Inc.·1978-05-03
K780697 — GOAT ANTI-INFLUENZA ANTISERA ATEXASNortheast Biomedical Labs., Inc.·1978-05-03
K780273 — INFLUENZA HI PRESERUMFlow Laboratories, Inc.·1978-02-28
K780274 — INFLUENZA HI ANTISERUMFlow Laboratories, Inc.·1978-02-28
K780276 — INFLUENZA HI ANTISERUM A/TEXASFlow Laboratories, Inc.·1978-02-28
K780277 — INFLUENZA HI PRESERUM A/TEXASFlow Laboratories, Inc.·1978-02-28
K780004 — GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.·1978-01-20
K780005 — GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.·1978-01-20
K780006 — GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.·1978-01-20

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