Product code GQN— Microbiology
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
- Classification name
- Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 34
- First cleared
- Most recent
Market context for product code GQN
FDA has cleared devices under product code GQN between 1979 and 2007, filed by 22 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
last 15 years- 2007
- 1999
- 1997
- 1996
- 1995
- 1991
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1981
- 1980
- 1979
Top applicants under product code GQN
Recent clearances under product code GQN
- K070265 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
- K063798 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
- K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
- K971662 — ELVIS HSV ID/TYPING TEST SYSTEM
- K964874 — HSV-1 ANTIGEN CONTROL SLIDES
- K971101 — HSV-2 ANTIGEN CONTROL SLIDES
- K960578 — ELVIS HSV GOLD
- K941924 — ELVIS HSV
- K911345 — HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
- K884761 — MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
- K883684 — HERPES VIRUS CONTROL SLIDES
- K873529 — HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
- K875311 — WELLCOZYME HSV WZO2
- K880604 — COLORGENE HSV DNA HYBRIDIZATION TEST
- K880996 — FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
- K881180 — FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
- K872632 — DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
- K880436 — MICROTRAK HSV CULTURE IDENTIFICATION TEST
- K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
- K870733 — COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
- K870602 — IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
- K854974 — HSV IDR
- K854488 — ORTHO HSV ANTIGEN ELISA TEST
- K853307 — DIRECT ELISA FOR HERPES SIMPLEX VIRUS
- K842830 — IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
- K843658 — H. SIMPLEX VIRUS
- K850609 — HERPES SIMPLEX GROUP CF ANTIGEN
- K843751 — CORDIA HS ANTIBODY TYPING REAGENTS
- K841191 — MICROTRAKSPECIMAN ID TYPING TEST CONTR
- K832541 — SIMPLEX-2
- K832875 — CORDIA HS
- K811021 — HERPES
- K801721 — HSV BIO-BEAD TITRATION KIT
- K791614 — HSV BIO-BEAD SCREEN KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.