Product code GQX— Microbiology

FDA has cleared 11 devices under product code GQX between 1977 and 1996, filed by 9 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.

• 19961 clearance
• 19911 clearance
• 19891 clearance
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19852 clearances
• 19841 clearance
• 19772 clearances

• Gull Laboratories, Inc.2 clearances
• Flow Laboratories, Inc.2 clearances
• Ortho Diagnostic Systems, Inc.1 clearance
• Microbix Biosystems, Inc.1 clearance
• Light Diagnostics1 clearance
• Idt, A Division of Whittaker M.A. Bioproducts1 clearance
• Great Lakes Bioscience1 clearance
• Electro-Nucleonics, Inc.1 clearance
• Behring Diagnostics, Inc.1 clearance

• K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight Diagnostics·1996-03-20
• K911301 — VZV IGM TESTGull Laboratories, Inc.·1991-07-17
• K883427 — VIRGO(R) VZV-IGG ELISAElectro-Nucleonics, Inc.·1989-03-10
• K875358 — VZV TESTGull Laboratories, Inc.·1988-03-31
• K863317 — ENZYGNOST ANTI-VZV IGG TESTBehring Diagnostics, Inc.·1987-04-22
• K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGYIdt, A Division of Whittaker M.A. Bioproducts·1986-02-04
• K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROMicrobix Biosystems, Inc.·1985-11-12
• K842096 — GLB VARICELLA-ZOSTER VIRUS FLUORESCENTGreat Lakes Bioscience·1985-01-07
• K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT.Ortho Diagnostic Systems, Inc.·1984-06-25
• K770806 — VARICELLA-ZOSTER FA LABELLED (8-321 RF)Flow Laboratories, Inc.·1977-05-20
• K770810 — VARICELLA-ZOSTER FA LABELED PRESERUMFlow Laboratories, Inc.·1977-05-20