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GQO — Antisera, Cf, Herpesvirus Hominis 1,2 Class II

FDA Device Classification

Classification Details

Product Code
GQO
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
K883282electro-nucleonicsVIRGO HSV-1 IGG ELISAMarch 10, 1989
K883281electro-nucleonicsVIRGO HSV-2 IGG ELISAMarch 10, 1989
K881261bion entBION HSV1-G OR HSV2-G TEST SYSTEMJune 7, 1988
K875366disease detection internationalTHE DDI SERODOT HERPES IGG TEST KITMay 23, 1988
K871426armkelVIROGEN HSV ANTIBODY TESTOctober 15, 1987
K861120microbiological researchTHE GOLDEN QUAD TEST (HSV)February 2, 1987
K854712isolabVISIBLE-HERPES TM TEST SYSTEMMay 20, 1986
K852781clinical sciencesHSV2 - IGG ELISA-KITJanuary 21, 1986
K852782clinical sciencesHSVI - IGG ELISA-KITJanuary 21, 1986
K842663amico labANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2December 6, 1985
K842531amico labAMIZYME-HSV TYPES 1 & 2 TEST KITSDecember 6, 1985
K852931microbix biosystemsHERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLTNovember 12, 1985
K841245behring diagnosticsENZYGNOST ANTIHERPES SIMPLEX VIRUSNovember 5, 1985
K852928armkelVIROGEN HERPES SLIDE TESTOctober 17, 1985
K842887scientific researchHERPES VIRUS AGGLUTINATION TESTFebruary 26, 1985
K791058electro-nucleonics laboratoriesANTIBODY TO HERPESVIRUS HOMINISSeptember 7, 1979