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LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Class II

FDA Device Classification

Classification Details

Product Code
LGC
Device Class
Class II
Regulation Number
866.3305
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K033059trinity biotechHERPES GROUP IGGNovember 26, 2003
K010878diagnostic productsMODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6April 18, 2001
K002262diamedixDIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMNovember 28, 2000
K000238mrl diagnosticsHSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GApril 14, 2000
K992166zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYMSeptember 3, 1999
K983886diagnologyPOCKIT HSV 2 RAPID TESTAugust 19, 1999
K984346meridian diagnosticsPREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTJune 25, 1999
K983656zeus scientificHSV-1 AND/OR -2 IGM ELISA TEST SYSTEMMarch 18, 1999
K983541gull laboratoriesHSV 1+2 IGG ELISA TESTFebruary 26, 1999
K981306diamedixDIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEMSeptember 29, 1998
K963645armkelHERPES GROUP IGG ELISA TEST SYSTEMFebruary 4, 1997
K963282quest intlSERAQUEST HSV IGGJanuary 22, 1997
K950670diagnostic productsIMMULITE HERPES I AND II IGGJune 21, 1996
K953839meridian diagnosticsPREMIER HSV PLUSMay 23, 1996
K925208ortho diagnostic systemsORTHO HSV ANTIGEN ELISA TEST, MODIFICATIONDecember 28, 1992
K922333baxter diagnosticsBARTELS HERPES SIMPLEX VIRUS 2 IGM EIADecember 15, 1992
K922334baxter diagnosticsBARTELS HERPES SIMPLEX VIRUS 1 IGM EIADecember 15, 1992
K922758gull laboratoriesHSV-1 IGM ELISA TEST -- MODIFICATIONOctober 5, 1992
K922759gull laboratoriesHSV-2 IGM ELISA TEST--MODIFICATIONOctober 5, 1992
K922583baxter diagnosticsBARTELS HERPES SIMPLEX VIRUS 2 IGG EIASeptember 28, 1992