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GOD — Antigens, Cf (Including Cf Control), Adenovirus 1-33 Class I

FDA Device Classification

Classification Details

Product Code
GOD
Device Class
Class I
Regulation Number
866.3020
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K110722rapid pathogen screeningRPS ADENO DETECTOR PLUSMay 17, 2011
K052092rapid pathogen screeningRPS ADENO DETECTORNovember 22, 2005
K990630sa scientificSAS ADENO TESTAugust 19, 1999
K972406immunoprobeADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMDecember 22, 1997
K881894cambridge bioscienceADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)July 8, 1988
K873312cambridge bioscienceADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TESTFebruary 24, 1988
K873082cambridge bioscienceADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTFebruary 24, 1988
K871229microscan div. baxter healthcareANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELLJune 26, 1987
K864645orion diagnosticaADENOLEX (R) LATEX AGGLUTINATION TESTJune 4, 1987
K843649institute virionADENOVIRUSSeptember 26, 1985
K802929orion diagnosticaADENO VIRUS & CONTROLSDecember 31, 1980