Product code GNT— Microbiology

FDA has cleared 5 devices under product code GNT between 1978 and 1996, filed by 3 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.

• 19961 clearance
• 19911 clearance
• 19901 clearance
• 19782 clearances

• Flow Laboratories, Inc.2 clearances
• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Zymetx, Inc.1 clearance

• K950838 — VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSESZymetx, Inc.·1996-06-17
• K913828 — QTEST INFLUENZA ABd Becton Dickinson Vacutainer Systems Preanalytic·1991-09-23
• K902609 — DIRECTIGEN FLU ABd Becton Dickinson Vacutainer Systems Preanalytic·1990-09-10
• K780272 — INFLUENZA HA ANTIGENFlow Laboratories, Inc.·1978-02-28
• K780275 — INFLUENZA HA ANTIGEN A/USSRFlow Laboratories, Inc.·1978-02-28