GQO — Antisera, Cf, Herpesvirus Hominis 1,2 Class II
FDA product code GQO covers "Antisera, Cf, Herpesvirus Hominis 1,2", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GQO
- 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 |
|---|---|---|---|
| K883282 | electro-nucleonics | VIRGO HSV-1 IGG ELISA | March 10, 1989 |
| K883281 | electro-nucleonics | VIRGO HSV-2 IGG ELISA | March 10, 1989 |
| K881261 | bion ent | BION HSV1-G OR HSV2-G TEST SYSTEM | June 7, 1988 |
| K875366 | disease detection international | THE DDI SERODOT HERPES IGG TEST KIT | May 23, 1988 |
| K871426 | armkel | VIROGEN HSV ANTIBODY TEST | October 15, 1987 |
| K861120 | microbiological research | THE GOLDEN QUAD TEST (HSV) | February 2, 1987 |
| K854712 | isolab | VISIBLE-HERPES TM TEST SYSTEM | May 20, 1986 |
| K852781 | clinical sciences | HSV2 - IGG ELISA-KIT | January 21, 1986 |
| K852782 | clinical sciences | HSVI - IGG ELISA-KIT | January 21, 1986 |
| K842531 | amico lab | AMIZYME-HSV TYPES 1 & 2 TEST KITS | December 6, 1985 |
| K842663 | amico lab | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | December 6, 1985 |
| K852931 | microbix biosystems | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT | November 12, 1985 |
| K841245 | behring diagnostics | ENZYGNOST ANTIHERPES SIMPLEX VIRUS | November 5, 1985 |
| K852928 | armkel | VIROGEN HERPES SLIDE TEST | October 17, 1985 |
| K842887 | scientific research | HERPES VIRUS AGGLUTINATION TEST | February 26, 1985 |
| K791058 | electro-nucleonics laboratories | ANTIBODY TO HERPESVIRUS HOMINIS | September 7, 1979 |