Product code GQN
- Device name
- Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3305
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070265 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 | Diagnostic Hybrids, Inc. | 2007-10-24 |
| K063798 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 | Diagnostic Hybrids, Inc. | 2007-09-21 |
| K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | Light Diagnostics | 1999-11-09 |
| K971662 | ELVIS HSV ID/TYPING TEST SYSTEM | Diagnostic Hybrids, Inc. | 1997-11-18 |
| K971101 | HSV-2 ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-07-01 |
| K964874 | HSV-1 ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-07-01 |
| K960578 | ELVIS HSV GOLD | Diagnostic Hybrids, Inc. | 1996-09-05 |
| K941924 | ELVIS HSV | Diagnostic Hybrids, Inc. | 1995-05-01 |
| K911345 | HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT | Diagnostic Hybrids, Inc. | 1991-06-17 |
| K884761 | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. | Difco Laboratories, Inc. | 1988-12-05 |
| K883684 | HERPES VIRUS CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-09-28 |
| K873529 | HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT | Diagnostic Hybrids, Inc. | 1988-08-25 |
| K880604 | COLORGENE HSV DNA HYBRIDIZATION TEST | Enzo Biochem, Inc. | 1988-08-03 |
| K875311 | WELLCOZYME HSV WZO2 | Wellcome Diagnostics | 1988-08-03 |
| K881180 | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG | Whittaker Bioproducts, Inc. | 1988-05-13 |
| K880996 | FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG | Whittaker Bioproducts, Inc. | 1988-05-13 |
| K872632 | DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT | E.I. Dupont DE Nemours & Co., Inc. | 1988-02-18 |
| K880436 | MICROTRAK HSV CULTURE IDENTIFICATION TEST | Syva Co. | 1988-02-18 |
| K874863 | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) | Monoclonal Antibodies, Inc. | 1988-02-16 |
| K870733 | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. | Enzo Biochem, Inc. | 1987-05-26 |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | Boots-Celltech Diagnostics, Inc. | 1987-05-08 |
| K854974 | HSV IDR | Genus Diagnostics | 1986-03-07 |
| K854488 | ORTHO HSV ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1986-02-04 |
| K853307 | DIRECT ELISA FOR HERPES SIMPLEX VIRUS | Fairleigh Dickinson Laboratories, Inc. | 1985-12-23 |
| K842830 | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF | Bartels Immunodiagnostic Supplies, Inc. | 1985-11-26 |
| K843658 | H. SIMPLEX VIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K850609 | HERPES SIMPLEX GROUP CF ANTIGEN | Hillcrest Biologicals | 1985-05-09 |
| K843751 | CORDIA HS ANTIBODY TYPING REAGENTS | Cordis Corp. | 1985-04-24 |
| K841191 | MICROTRAKSPECIMAN ID TYPING TEST CONTR | Syva Co. | 1984-06-19 |
| K832541 | SIMPLEX-2 | Gentech Australia | 1984-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04053252625213 | Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent | EMD Millipore Corporation | 2020-04-16 |
| 04053252515101 | Light Diagnostics SimulFluor HSV 1/2 | EMD Millipore Corporation | 2020-04-16 |
| 30014613336020 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-04-02 |
| 30014613336013 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-04-02 |
| 30014613330127 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330165 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330110 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330158 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330196 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330202 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613333043 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332985 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333005 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332961 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332954 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332978 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333081 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333074 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333067 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333050 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333036 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333029 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333012 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332992 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613330691 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330721 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |
| 30014613330738 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-21 |
| 30014613330714 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-20 |
| 30014613330684 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |
| 30014613330707 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |