Atlas FDA

GQI

18 FDA 510(k) clearances · Product code

185 daysmedian time to decision
514 days90th percentile
18clearances measured

FDA profile

Official device name
Antiserum, Cf, Cytomegalovirus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3175
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (K952254)Pyramid Biological Corp.1995-11-16
CMV IGG HUMAN SERUM CONTROLS (K951800)Pyramid Biological Corp.1995-11-16
CMV EARLY ANTIGEN TEST (K942171)Neogenex1994-06-30
VIRGO (R) CMV-IGG ELISA (K883102)Electro-Nucleonics, Inc.1989-02-08
DETECTADOT SYSTEM 2000 CMV IGG TEST (K875159)Gull Laboratories, Inc.1988-05-06
ENZYGNOST ANTI-CMV IGG TEST (K863488)Behring Diagnostics, Inc.1987-07-20
CMV MICROASSAY (K864420)Diamedix Corp.1987-02-02
THE GOLDEN QUAD TEST (CMV) (K861123)Microbiological Research Corp.1987-02-02
CYTOMEGALOVIRUS IGG EIA TEST KIT (K862705)Labsystems, Inc.1986-10-01
COR DOT CMV (K853989)Cordis Corp.1986-06-13
CYTOTECH CMV IGG EIA (K860493)Cytotech, Inc.1986-05-20
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 (K854666)Clinical Sciences, Inc.1986-02-05
CYTOMEGALOVIRUS IGG EIA TEST KIT (K843189)Labsystems, Inc.1986-01-08
ANTI-CYTOMEGALOVIRUS KIT (K842661)Amico Lab, Inc.1985-12-06
AMIZYME-CMV KIT (K842529)Amico Lab, Inc.1985-12-06
CMV TEST (K853137)Gull Laboratories, Inc.1985-11-14
CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (K852929)Microbix Biosystems, Inc.1985-11-12
CMV CF ANTIGEN (K853277)Hillcrest Biologicals1985-11-07

Track GQI automatically

Every clearance here is in the API, with alerts when new ones post.