GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | GQL |
|---|---|
| Device Name | Antisera, Fluorescent, 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 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | Diagnostic Hybrids, Inc. | Aug 28, 2009 | SESE |
| K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | Millipore Corporation | Apr 1, 2009 | SESE |
| K984135 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | May 26, 1999 | SESE |
| K984120 | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | Zeus Scientific, Inc. | May 26, 1999 | SESE |
| K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | Stellar Bio Systems, Inc. | Nov 7, 1991 | SESE |
| K904095 | HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING | California Integrated Diagnostics, Inc. | Feb 1, 1991 | SESE |
| K904167 | PATHODX HERPES TYPING | Diagnostic Products Corp. | Dec 13, 1990 | SESE |
| K902662 | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST | Baxter Healthcare Corp | Jul 31, 1990 | SESE |
| K902661 | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 | Baxter Healthcare Corp | Jul 31, 1990 | SESE |
| K891782 | HSV-2 ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jun 20, 1989 | SESE |
| K891162 | HSV-1 ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jun 20, 1989 | SESE |
| K891382 | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | Ortho Diagnostic Systems, Inc. | Jun 6, 1989 | SESE |
| K870814 | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 | Microscan Div. Baxter Healthcare Corp. | Jun 4, 1987 | SESE |
| K851635 | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | Diagnon Corp. | Oct 10, 1985 | SESE |
| K852360 | ORTHO DNA PROBE HSV CONFIRMATION TEST | Ortho Diagnostic Systems, Inc. | Sep 12, 1985 | SESE |
| K852125 | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | Kallestad Laboratories, Inc. | Jul 30, 1985 | SESE |
| K851372 | CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS | Difco Laboratories, Inc. | Jul 12, 1985 | SESE |
| K841943 | GIBCO HERPES ID KIT | Gibco Laboratories Life Technologies, Inc. | Mar 13, 1985 | SESE |
| K850739 | AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT | Syva Co. | Mar 11, 1985 | SESE |
| K842216 | CULTURESET HSV ISOLATION & ID SYS | Ortho Diagnostic Systems, Inc. | Jan 29, 1985 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 5 clearances
- Syva Co. — 4 clearances
- Immulok, Inc. — 4 clearances
- Ortho Diagnostic Systems, Inc. — 3 clearances
- Gull Laboratories, Inc. — 2 clearances
