GQN · Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | GQN |
|---|---|
| Device Name | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 |
| Regulation | 21 CFR 866.3305 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
Classification Rationale
Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Special Controls
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070265 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 | Diagnostic Hybrids, Inc. | Oct 24, 2007 | SESE |
| K063798 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 | Diagnostic Hybrids, Inc. | Sep 21, 2007 | SESE |
| K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | Light Diagnostics | Nov 9, 1999 | SESE |
| K971662 | ELVIS HSV ID/TYPING TEST SYSTEM | Diagnostic Hybrids, Inc. | Nov 18, 1997 | SESE |
| K971101 | HSV-2 ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | Jul 1, 1997 | SESE |
| K964874 | HSV-1 ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | Jul 1, 1997 | SESE |
| K960578 | ELVIS HSV GOLD | Diagnostic Hybrids, Inc. | Sep 5, 1996 | SESE |
| K941924 | ELVIS HSV | Diagnostic Hybrids, Inc. | May 1, 1995 | SESE |
| K911345 | HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT | Diagnostic Hybrids, Inc. | Jun 17, 1991 | SESE |
| K884761 | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. | Difco Laboratories, Inc. | Dec 5, 1988 | SESE |
| K883684 | HERPES VIRUS CONTROL SLIDES | Val Tech Diagnostics, Inc. | Sep 28, 1988 | SESE |
| K873529 | HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT | Diagnostic Hybrids, Inc. | Aug 25, 1988 | SESE |
| K880604 | COLORGENE HSV DNA HYBRIDIZATION TEST | Enzo Biochem, Inc. | Aug 3, 1988 | SESE |
| K875311 | WELLCOZYME HSV WZO2 | Wellcome Diagnostics | Aug 3, 1988 | SESE |
| K881180 | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG | Whittaker Bioproducts, Inc. | May 13, 1988 | SESE |
| K880996 | FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG | Whittaker Bioproducts, Inc. | May 13, 1988 | SESE |
| K880436 | MICROTRAK HSV CULTURE IDENTIFICATION TEST | Syva Co. | Feb 18, 1988 | SESE |
| K872632 | DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT | E.I. Dupont DE Nemours & Co., Inc. | Feb 18, 1988 | SESE |
| K874863 | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) | Monoclonal Antibodies, Inc. | Feb 16, 1988 | SESE |
| K870733 | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. | Enzo Biochem, Inc. | May 26, 1987 | SESE |
Top Applicants
- Diagnostic Hybrids, Inc. — 7 clearances
- Cordis Corp. — 2 clearances
- Enzo Biochem, Inc. — 2 clearances
- Litton Bionetics — 2 clearances
- Syva Co. — 2 clearances
