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LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa Class I

FDA Device Classification

Classification Details

Product Code
LKT
Device Class
Class I
Regulation Number
866.3480
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K081928diagnostic hybridsD3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDecember 23, 2008
K983336diagnostic productsPATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1March 18, 1999
K943317diagnostic productsPATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)December 19, 1994
K942173neogenexRSV ANTIGEN TESTJune 30, 1994
K912842gull laboratoriesRSV-MAB TESTDecember 9, 1991
K912838baxter diagnosticsBARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOSeptember 27, 1991
K912371vitek systemsBIOMERIEUX RSV DIRECT IF KITSeptember 23, 1991
K894623bion entRESPIRATORY SYNCYTIAL VIRUSOctober 16, 1989
K884192baxter diagnosticsRSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTIONNovember 22, 1988
K882687gull laboratoriesANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TESTAugust 30, 1988
K873564genetic systemsGENETIC SYSTEMS RSV REAGENT CONTROL SLIDESNovember 20, 1987
K872701sitaRESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROLSeptember 18, 1987
K872082medical diagnostic technologiesRESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDEJuly 31, 1987
K870176genetic systemsGENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KITJuly 16, 1987
K871230microscan div. baxter healthcareANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUSJune 26, 1987
K862321difco laboratoriesCELLMATICS RSV DETECTION SYSTEMAugust 21, 1986
K861379serono diagnosticsMONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KITJuly 16, 1986
K852472abbott laboratoriesABBOTT RSV EIASeptember 17, 1985
K852185bartels immunodiagnostic suppliesRESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANTAugust 19, 1985
K844721innotron diagnosticsINNOFLUOR PRIMIDONEJanuary 8, 1985