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LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus Class II

FDA Device Classification

FDA product code LIN covers "Antisera, Conjugated Fluorescent, Cytomegalovirus", a Class II medical device regulated under 21 CFR 866.3175. Submissions are reviewed by the Microbiology panel. At least 17 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LIN
Device Class
Class II
Regulation Number
866.3175
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K081164diagnostic hybridsD3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITJune 13, 2008
K983762organon teknikaNUCLISENS CMV PP67September 15, 1999
K991650biotest diagnosticsCMV BRITE TURBO KITJuly 12, 1999
K951821light diagnosticsCYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYJune 7, 1996
K951550biotest diagnosticsCMV BRITE ANTIGENEMIA TEST KITJanuary 30, 1996
K934798diagnostic productsPATHODX CYTOMEGALOVIRUSMarch 25, 1994
K921616incstarCMV-VUE(TM) CMV ANTIGEN DETECTION KITAugust 11, 1992
K912592gull laboratoriesCMV-EA MAB TESTDecember 4, 1991
K905257pb diagnostic systemsOPUS CMV TEST SYSTEMApril 17, 1991
K904036baxter healthcareBARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGENOctober 16, 1990
K894002baxter healthcareCYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODYAugust 10, 1989
K893467immuno conceptsCMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)July 14, 1989
K893468immuno conceptsCMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)July 14, 1989
K860279bartels immunodiagnostic suppliesCYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITMay 13, 1986
K843138microbiological researchCMV TESTJanuary 29, 1985
K822606immulokCYTOMEGALOVIRUS ANTOBODY IGGNovember 1, 1982
K820895bartels immunodiagnostic suppliesCYLOMEGALOVIRUS DIRECT FLUORESCENT ANTIMay 3, 1982

FDA data resources