Product code GQI— Microbiology
CYTOMEGALOVIRUS IGG EIA TEST KIT
- Classification name
- Antiserum, Cf, Cytomegalovirus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code GQI
FDA has cleared devices under product code GQI between 1985 and 1995, filed by 14 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
- 1995
- 1994
- 1989
- 1988
- 1987
- 1986
- 1985
Top applicants under product code GQI
Recent clearances under product code GQI
- K951800 — CMV IGG HUMAN SERUM CONTROLS
- K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
- K942171 — CMV EARLY ANTIGEN TEST
- K883102 — VIRGO (R) CMV-IGG ELISA
- K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST
- K863488 — ENZYGNOST ANTI-CMV IGG TEST
- K861123 — THE GOLDEN QUAD TEST (CMV)
- K864420 — CMV MICROASSAY
- K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT
- K853989 — COR DOT CMV
- K860493 — CYTOTECH CMV IGG EIA
- K854666 — CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
- K843189 — CYTOMEGALOVIRUS IGG EIA TEST KIT
- K842529 — AMIZYME-CMV KIT
- K842661 — ANTI-CYTOMEGALOVIRUS KIT
- K853137 — CMV TEST
- K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
- K853277 — CMV CF ANTIGEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.