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NBT — Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) Class II

FDA Device Classification

Classification Details

Product Code
NBT
Device Class
Class II
Regulation Number
866.5785
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K071711techlab inc., corporate research centerASCA-CHEKNovember 7, 2007
K051927techlabTECHLAB ASCA-CHEKApril 6, 2006
K051492aeskuAESKULISA ASCA ANovember 14, 2005
K042579binding siteBINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITJuly 28, 2005
K032860immco diagnosticsIMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)March 18, 2004
K032850immco diagnosticsIMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)March 18, 2004
K000733inova diagnosticsQUANTA LITE ASCA (S. CEREVISIAE) IGA ELISAMay 21, 2001
DEN000007inova diagnosticsQUANTA LITE ASCA (S. CEREVISIAE) IGG ELISAAugust 16, 2000