Product code GQL
- Device name
- Antisera, Fluorescent, 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 |
|---|---|---|---|
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | Diagnostic Hybrids, Inc. | 2009-08-28 |
| K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | Millipore Corporation | 2009-04-01 |
| K984135 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | 1999-05-26 |
| K984120 | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | Zeus Scientific, Inc. | 1999-05-26 |
| K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | Stellar Bio Systems, Inc. | 1991-11-07 |
| K904095 | HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING | California Integrated Diagnostics, Inc. | 1991-02-01 |
| K904167 | PATHODX HERPES TYPING | Diagnostic Products Corp. | 1990-12-13 |
| K902662 | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST | Baxter Healthcare Corp | 1990-07-31 |
| K902661 | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 | Baxter Healthcare Corp | 1990-07-31 |
| K891782 | HSV-2 ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1989-06-20 |
| K891162 | HSV-1 ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1989-06-20 |
| K891382 | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | Ortho Diagnostic Systems, Inc. | 1989-06-06 |
| K870814 | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 | Microscan Div. Baxter Healthcare Corp. | 1987-06-04 |
| K851635 | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | Diagnon Corp. | 1985-10-10 |
| K852360 | ORTHO DNA PROBE HSV CONFIRMATION TEST | Ortho Diagnostic Systems, Inc. | 1985-09-12 |
| K852125 | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | Kallestad Laboratories, Inc. | 1985-07-30 |
| K851372 | CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS | Difco Laboratories, Inc. | 1985-07-12 |
| K841943 | GIBCO HERPES ID KIT | Gibco Laboratories Life Technologies, Inc. | 1985-03-13 |
| K850739 | AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT | Syva Co. | 1985-03-11 |
| K842216 | CULTURESET HSV ISOLATION & ID SYS | Ortho Diagnostic Systems, Inc. | 1985-01-29 |
| K841190 | MICROTRAK HSV 1 & 2 DIRECT SPECIMAN | Syva Co. | 1985-01-18 |
| K841680 | SCOTT SELECTICULT-HSV ISOLATION & | Scott Laboratories, Inc. | 1984-10-30 |
| K840494 | MICROTRAK HSV 1 & 2 CULTURE | Syva Co. | 1984-05-07 |
| K831504 | HERPES IDENT. & TYPING TEST HITT | Electro-Nucleonics Laboratories, Inc. | 1983-09-20 |
| K830865 | HSV IGM TEST | Gull Laboratories, Inc. | 1983-07-18 |
| K830623 | INDIRECT FLUORO-KIT HSV | Clinical Sciences, Inc. | 1983-07-07 |
| K830971 | HERPES SIMPLEX VIRUS TYPING REAGENTS | Immulok, Inc. | 1983-06-30 |
| K830953 | MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION | Syva Co. | 1983-06-22 |
| K822785 | FLUOROSET IMMUNOFLUORESCENT ANTIBODY | Immulok, Inc. | 1982-11-29 |
| K821567 | IMMULOK CULTURESET | Immulok, Inc. | 1982-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G5229025001 | Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229025011 | Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G522902600 | Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229026011 | Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit | Hemagen Diagnostics, Inc. | 2023-10-05 |
| 04053252278679 | Light Diagnostics HSV 1 & 2 Control Slides (5 Pack) | EMD Millipore Corporation | 2020-04-16 |
| 04053252670930 | Light Diagnostics HSV 2 Typing Reagent | EMD Millipore Corporation | 2020-04-16 |
| 04053252678257 | Light Diagnostics HSV 1 Typing Reagent | EMD Millipore Corporation | 2020-04-16 |
| 04061841047469 | Light Diagnostics HSV 1 & 2 Control Slide | EMD Millipore Corporation | 2020-04-16 |
| 30014613336013 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-04-02 |
| 30014613336020 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-04-02 |
| 30014613330165 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330202 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330196 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330158 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330127 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330110 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613333029 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333036 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333050 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333067 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333074 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333012 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332992 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332985 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613332978 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333098 | ELVIS | DIAGNOSTIC HYBRIDS, INC. | 2018-08-07 |
| 30014613333043 | 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 |