GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 Class II
FDA product code GQL covers "Antisera, Fluorescent, Herpesvirus Hominis 1,2", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |