Product code GQL— Microbiology
AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
- Classification name
- Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 37
- First cleared
- Most recent
Market context for product code GQL
FDA has cleared devices under product code GQL between 1977 and 2009, filed by 23 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.
Clearances per year
- 2009
- 1999
- 1991
- 1990
- 1989
- 1987
- 1985
- 1984
- 1983
- 1982
- 1981
- 1980
- 1977
Top applicants under product code GQL
Recent clearances under product code GQL
- K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM
- K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
- K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
- K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
- K904167 — PATHODX HERPES TYPING
- K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
- K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
- K891162 — HSV-1 ELISA TEST SYSTEM
- K891782 — HSV-2 ELISA TEST SYSTEM
- K891382 — ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
- K870814 — HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
- K851635 — DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
- K852360 — ORTHO DNA PROBE HSV CONFIRMATION TEST
- K852125 — PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
- K851372 — CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
- K841943 — GIBCO HERPES ID KIT
- K850739 — AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
- K842216 — CULTURESET HSV ISOLATION & ID SYS
- K841190 — MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
- K841680 — SCOTT SELECTICULT-HSV ISOLATION &
- K840494 — MICROTRAK HSV 1 & 2 CULTURE
- K831504 — HERPES IDENT. & TYPING TEST HITT
- K830865 — HSV IGM TEST
- K830623 — INDIRECT FLUORO-KIT HSV
- K830971 — HERPES SIMPLEX VIRUS TYPING REAGENTS
- K830953 — MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
- K822785 — FLUOROSET IMMUNOFLUORESCENT ANTIBODY
- K821411 — HISTOSET IMMUNOPEROFIDASE TISSUE
- K821567 — IMMULOK CULTURESET
- K812085 — HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
- K802590 — DIRECT FLUORESCENT ANTIBODY KIT/HERPES
- K803132 — HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT
- K792559 — FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
- K771445 — HERPES I.D. TM TEST
- K771063 — HSV TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.