ClearanceBrief
Panels › Microbiology › Product code GQI · Class 2

Antiserum, Cf, Cytomegalovirus

Regulation 866.3175

0510(k)s in 12 months (18 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in GQI

Company510(k)sRecalls
Amico Lab, Inc.20
Gull Laboratories, Inc.20
Labsystems, Inc.20
Pyramid Biological Corp.20
Behring Diagnostics, Inc.10
Clinical Sciences, Inc.10
Cordis Corp.10
Cytotech, Inc.10
Diamedix Corp.10
Electro-Nucleonics, Inc.10
Decided510(k)Device and applicantCode
Nov 16, 1995K952254ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
Pyramid Biological Corp.
GQI
Nov 16, 1995K951800CMV IGG HUMAN SERUM CONTROLS
Pyramid Biological Corp.
GQI
Jun 30, 1994K942171CMV EARLY ANTIGEN TEST
Neogenex
GQI
Feb 8, 1989K883102VIRGO (R) CMV-IGG ELISA
Electro-Nucleonics, Inc.
GQI
May 6, 1988K875159DETECTADOT SYSTEM 2000 CMV IGG TEST
Gull Laboratories, Inc.
GQI
Jul 20, 1987K863488ENZYGNOST ANTI-CMV IGG TEST
Behring Diagnostics, Inc.
GQI
Feb 2, 1987K864420CMV MICROASSAY
Diamedix Corp.
GQI
Feb 2, 1987K861123THE GOLDEN QUAD TEST (CMV)
Microbiological Research Corp.
GQI
Oct 1, 1986K862705CYTOMEGALOVIRUS IGG EIA TEST KIT
Labsystems, Inc.
GQI
Jun 13, 1986K853989COR DOT CMV
Cordis Corp.
GQI
May 20, 1986K860493CYTOTECH CMV IGG EIA
Cytotech, Inc.
GQI
Feb 5, 1986K854666CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
Clinical Sciences, Inc.
GQI
Jan 8, 1986K843189CYTOMEGALOVIRUS IGG EIA TEST KIT
Labsystems, Inc.
GQI
Dec 6, 1985K842661ANTI-CYTOMEGALOVIRUS KIT
Amico Lab, Inc.
GQI
Dec 6, 1985K842529AMIZYME-CMV KIT
Amico Lab, Inc.
GQI
Nov 14, 1985K853137CMV TEST
Gull Laboratories, Inc.
GQI
Nov 12, 1985K852929CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
Microbix Biosystems, Inc., CA
GQI
Nov 7, 1985K853277CMV CF ANTIGEN
Hillcrest Biologicals
GQI

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