Product code GQO— Microbiology
AMIZYME-HSV TYPES 1 & 2 TEST KITS
- Classification name
- Antisera, Cf, Herpesvirus Hominis 1,2
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code GQO
FDA has cleared devices under product code GQO between 1979 and 1989, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1989
- 1988
- 1987
- 1986
- 1985
- 1979
Top applicants under product code GQO
Recent clearances under product code GQO
- K883281 — VIRGO HSV-2 IGG ELISA
- K883282 — VIRGO HSV-1 IGG ELISA
- K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM
- K875366 — THE DDI SERODOT HERPES IGG TEST KIT
- K871426 — VIROGEN HSV ANTIBODY TEST
- K861120 — THE GOLDEN QUAD TEST (HSV)
- K854712 — VISIBLE-HERPES TM TEST SYSTEM
- K852781 — HSV2 - IGG ELISA-KIT
- K852782 — HSVI - IGG ELISA-KIT
- K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS
- K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
- K852931 — HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
- K841245 — ENZYGNOST ANTIHERPES SIMPLEX VIRUS
- K852928 — VIROGEN HERPES SLIDE TEST
- K842887 — HERPES VIRUS AGGLUTINATION TEST
- K791058 — ANTIBODY TO HERPESVIRUS HOMINIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.