Atlas FDA

GQH

19 FDA 510(k) clearances · Product code

92 daysmedian time to decision
233 days90th percentile
19clearances measured

FDA profile

Official device name
Antigen, Cf (Including Cf Control), 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
BARTELS CINAKIT CMV ANTIGENEMIA (K982311)Intracel Corp.1998-12-14
CMV ANTIGEN CONTROL SLIDES (K964875)Viral Antigens, Inc.1997-03-18
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (K935809)Light Diagnostics1994-05-05
INDIRECT FLUORESCENT ASSAY FOR (HCMV) (K882835)Stellar Bio Systems, Inc.1988-12-05
FITC MURINE MONOCLONAL ANTI-CMV IGG (K882024)Whittaker Bioproducts, Inc.1988-08-03
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (K881932)Ortho Diagnostic Systems, Inc.1988-08-01
BION CMV-G TEST SYSTEM (K880679)Bion Ent., Ltd.1988-06-03
MICROTRAK CMV CULTURE CONFIRMATION TEST (K880290)Syva Co.1988-04-19
COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (K872576)Enzo Biochem, Inc.1987-12-04
CYTOMEGALOVIRUS CONTROL SLIDES (K873114)Medical Diagnostic Technologies, Inc.1987-09-25
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (K864565)Serono Diagnostics, Inc.1987-02-19
CYTOMEGALOVIRUS (K843657)Institute Virion , Ltd.1985-09-26
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II (K833089)Clinical Sciences, Inc.1984-05-02
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM (K811671)Zeus Scientific, Inc.1981-09-16
CYTOMEGALO VIRUS & CONTROLS (K802930)Orion Diagnostica, Inc.1981-01-09
CMV TEST KIT (K801963)Immuno-Diagnostic Products, Inc.1980-10-23
CMV BIO-BEAD TITRATION KIT (K801722)Litton Bionetics1980-09-16
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS (K791948)Intl. Diagnostic Technology1979-11-16
CMV BIO-BEAD SCREEN KIT (K791612)Litton Bionetics1979-11-13

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