GQO · Antisera, Cf, Herpesvirus Hominis 1,2
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | GQO |
|---|---|
| Device Name | Antisera, Cf, 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883282 | VIRGO HSV-1 IGG ELISA | Electro-Nucleonics, Inc. | Mar 10, 1989 | SESE |
| K883281 | VIRGO HSV-2 IGG ELISA | Electro-Nucleonics, Inc. | Mar 10, 1989 | SESE |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Bion Ent., Ltd. | Jun 7, 1988 | SESE |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | Disease Detection International, Inc. | May 23, 1988 | SESE |
| K871426 | VIROGEN HSV ANTIBODY TEST | Armkel, LLC | Oct 15, 1987 | SESE |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Microbiological Research Corp. | Feb 2, 1987 | SESE |
| K854712 | VISIBLE-HERPES TM TEST SYSTEM | Isolab, Inc. | May 20, 1986 | SESE |
| K852782 | HSVI - IGG ELISA-KIT | Clinical Sciences, Inc. | Jan 21, 1986 | SESE |
| K852781 | HSV2 - IGG ELISA-KIT | Clinical Sciences, Inc. | Jan 21, 1986 | SESE |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Amico Lab, Inc. | Dec 6, 1985 | SESE |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Amico Lab, Inc. | Dec 6, 1985 | SESE |
| K852931 | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT | Microbix Biosystems, Inc. | Nov 12, 1985 | SESE |
| K841245 | ENZYGNOST ANTIHERPES SIMPLEX VIRUS | Behring Diagnostics, Inc. | Nov 5, 1985 | SESE |
| K852928 | VIROGEN HERPES SLIDE TEST | Armkel, LLC | Oct 17, 1985 | SESE |
| K842887 | HERPES VIRUS AGGLUTINATION TEST | Scientific Research | Feb 26, 1985 | SESE |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | Electro-Nucleonics Laboratories, Inc. | Sep 7, 1979 | SESE |
Top Applicants
- Amico Lab, Inc. — 2 clearances
- Armkel, LLC — 2 clearances
- Clinical Sciences, Inc. — 2 clearances
- Electro-Nucleonics, Inc. — 2 clearances
- Behring Diagnostics, Inc. — 1 clearance
