Atlas FDA

LKT

23 FDA 510(k) clearances · Product code

91 daysmedian time to decision
169 days90th percentile
23clearances measured

FDA profile

Official device name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device class
Class I (low risk)
Regulation
21 CFR 866.3480
Medical specialty
Microbiology
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RecordFirmDate
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928)Diagnostic Hybrids, Inc.2008-12-23
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336)Diagnostic Products Corp.1999-03-18
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (K943317)Diagnostic Products Corp.1994-12-19
RSV ANTIGEN TEST (K942173)Neogenex1994-06-30
RSV-MAB TEST (K912842)Gull Laboratories, Inc.1991-12-09
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838)Baxter Diagnostics, Inc.1991-09-27
BIOMERIEUX RSV DIRECT IF KIT (K912371)Vitek Systems, Inc.1991-09-23
RESPIRATORY SYNCYTIAL VIRUS (K894623)Bion Ent., Ltd.1989-10-16
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (K884192)Baxter Diagnostics, Inc.1988-11-22
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687)Gull Laboratories, Inc.1988-08-30
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (K873564)Genetic Systems Corp.1987-11-20
RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL (K872701)Sita, Inc.1987-09-18
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE (K872082)Medical Diagnostic Technologies, Inc.1987-07-31
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (K870176)Genetic Systems Corp.1987-07-16
ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (K871230)Microscan Div. Baxter Healthcare Corp.1987-06-26
CELLMATICS RSV DETECTION SYSTEM (K862321)Difco Laboratories, Inc.1986-08-21
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT (K861379)Serono Diagnostics, Inc.1986-07-16
ABBOTT RSV EIA (K852472)Abbott Laboratories1985-09-17
RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT (K852185)Bartels Immunodiagnostic Supplies, Inc.1985-08-19
INNOFLUOR PRIMIDONE (K844721)Innotron Diagnostics1985-01-08
ORTHO* RSV ANTIGEN ELISA TEST SYS (K842047)Ortho Diagnostic Systems, Inc.1984-10-05
ORTHO RESPIRATORY SYNCYTIAL VIRUS- (K841527)Ortho Diagnostic Systems, Inc.1984-08-12
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS (K831924)Electro-Nucleonics Laboratories, Inc.1983-08-11

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