Product code GQH— Microbiology
BARTELS CINAKIT CMV ANTIGENEMIA
- Classification name
- Antigen, Cf (Including Cf Control), Cytomegalovirus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code GQH
FDA has cleared devices under product code GQH between 1979 and 1998, filed by 18 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
- 1998
- 1997
- 1994
- 1988
- 1987
- 1985
- 1984
- 1981
- 1980
- 1979
Top applicants under product code GQH
Recent clearances under product code GQH
- K982311 — BARTELS CINAKIT CMV ANTIGENEMIA
- K964875 — CMV ANTIGEN CONTROL SLIDES
- K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
- K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV)
- K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG
- K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
- K880679 — BION CMV-G TEST SYSTEM
- K880290 — MICROTRAK CMV CULTURE CONFIRMATION TEST
- K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
- K873114 — CYTOMEGALOVIRUS CONTROL SLIDES
- K864565 — MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
- K843657 — CYTOMEGALOVIRUS
- K833089 — CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
- K811671 — CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
- K802930 — CYTOMEGALO VIRUS & CONTROLS
- K801963 — CMV TEST KIT
- K801722 — CMV BIO-BEAD TITRATION KIT
- K791948 — FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
- K791612 — CMV BIO-BEAD SCREEN KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.