Product code GQO
- Device name
- Antisera, Cf, 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 |
|---|---|---|---|
| K883281 | VIRGO HSV-2 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 |
| K883282 | VIRGO HSV-1 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-07 |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | Disease Detection International, Inc. | 1988-05-23 |
| K871426 | VIROGEN HSV ANTIBODY TEST | Armkel, LLC | 1987-10-15 |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Microbiological Research Corp. | 1987-02-02 |
| K854712 | VISIBLE-HERPES TM TEST SYSTEM | Isolab, Inc. | 1986-05-20 |
| K852781 | HSV2 - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 |
| K852782 | HSVI - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Amico Lab, Inc. | 1985-12-06 |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Amico Lab, Inc. | 1985-12-06 |
| K852931 | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT | Microbix Biosystems, Inc. | 1985-11-12 |
| K841245 | ENZYGNOST ANTIHERPES SIMPLEX VIRUS | Behring Diagnostics, Inc. | 1985-11-05 |
| K852928 | VIROGEN HERPES SLIDE TEST | Armkel, LLC | 1985-10-17 |
| K842887 | HERPES VIRUS AGGLUTINATION TEST | Scientific Research | 1985-02-26 |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | Electro-Nucleonics Laboratories, Inc. | 1979-09-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05391516743464 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516743495 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516747028 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516747042 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05700572001614 | Poly Rb A-Herpes Simplex Virus Type 1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| B110HS130120 | Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110HS1G1200 | HSV-1 IgG Test System, 120 Tests | Bion Enterprises, Ltd. | 2016-09-12 |
| B110HS240120 | Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110HS2G1200 | HSV-2 IgG Test System, 120 Tests | Bion Enterprises, Ltd. | 2016-09-12 |
| B110HSG35200 | Herpes Simplex IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110HSM35300 | Herpes Simplex IgM Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110HSN35100 | Herpes Simplex Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |