GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 Class II
FDA Device Classification
Classification Details
- Product Code
- GQL
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K091753 | diagnostic hybrids | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | August 28, 2009 |
| K081527 | millipore corporation | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | April 1, 2009 |
| K984135 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME | May 26, 1999 |
| K984120 | zeus scientific | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L | May 26, 1999 |
| K905608 | stellar bio systems | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | November 7, 1991 |
| K904095 | california integrated diagnostics | HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING | February 1, 1991 |
| K904167 | diagnostic products | PATHODX HERPES TYPING | December 13, 1990 |
| K902662 | baxter healthcare | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST | July 31, 1990 |
| K902661 | baxter healthcare | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 | July 31, 1990 |
| K891162 | zeus scientific | HSV-1 ELISA TEST SYSTEM | June 20, 1989 |
| K891782 | zeus scientific | HSV-2 ELISA TEST SYSTEM | June 20, 1989 |
| K891382 | ortho diagnostic systems | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | June 6, 1989 |
| K870814 | microscan div. baxter healthcare | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 | June 4, 1987 |
| K851635 | diagnon | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | October 10, 1985 |
| K852360 | ortho diagnostic systems | ORTHO DNA PROBE HSV CONFIRMATION TEST | September 12, 1985 |
| K852125 | kallestad laboratories | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | July 30, 1985 |
| K851372 | difco laboratories | CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS | July 12, 1985 |
| K841943 | gibco laboratories life technologies | GIBCO HERPES ID KIT | March 13, 1985 |
| K850739 | syva | AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT | March 11, 1985 |
| K842216 | ortho diagnostic systems | CULTURESET HSV ISOLATION & ID SYS | January 29, 1985 |