GQN — Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 Class II
FDA product code GQN covers "Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GQN
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070265 | diagnostic hybrids | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, M | October 24, 2007 |
| K063798 | diagnostic hybrids | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080 | September 21, 2007 |
| K991880 | light diagnostics | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | November 9, 1999 |
| K971662 | diagnostic hybrids | ELVIS HSV ID/TYPING TEST SYSTEM | November 18, 1997 |
| K971101 | viral antigens | HSV-2 ANTIGEN CONTROL SLIDES | July 1, 1997 |
| K964874 | viral antigens | HSV-1 ANTIGEN CONTROL SLIDES | July 1, 1997 |
| K960578 | diagnostic hybrids | ELVIS HSV GOLD | September 5, 1996 |
| K941924 | diagnostic hybrids | ELVIS HSV | May 1, 1995 |
| K911345 | diagnostic hybrids | HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT | June 17, 1991 |
| K884761 | difco laboratories | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. | December 5, 1988 |
| K883684 | val tech diagnostics | HERPES VIRUS CONTROL SLIDES | September 28, 1988 |
| K873529 | diagnostic hybrids | HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT | August 25, 1988 |
| K880604 | enzo biochem | COLORGENE HSV DNA HYBRIDIZATION TEST | August 3, 1988 |
| K875311 | wellcome diagnostics | WELLCOZYME HSV WZO2 | August 3, 1988 |
| K880996 | whittaker bioproducts | FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG | May 13, 1988 |
| K881180 | whittaker bioproducts | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG | May 13, 1988 |
| K872632 | e.i. dupont de nemours and co | DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT | February 18, 1988 |
| K880436 | syva | MICROTRAK HSV CULTURE IDENTIFICATION TEST | February 18, 1988 |
| K874863 | monoclonal antibodies | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) | February 16, 1988 |
| K870733 | enzo biochem | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. | May 26, 1987 |