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DEM — Alpha-1-Antitrypsin, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DEM
Device Class
Class II
Regulation Number
866.5130
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123256binding site groupHUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSJuly 3, 2013
K063610dade behringDIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROLJanuary 11, 2007
K053072dade behringN ANTISERA TO HUMAN ALPHA1-ANTITRYPSINMarch 28, 2006
K052819ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERDecember 23, 2005
K050596biokitQUANTIA A1-ATMay 13, 2005
K031857bayer diagnosticsADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYSeptember 4, 2003
K011663binding siteMININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLSJuly 30, 2001
K010978rochdiagTINA-QUANT ALPHA-1 ANTITRYPSINMay 18, 2001
K993444kamiya biomedicalK-ASSAY ALPHA-1 ATNovember 24, 1999
K972640boehringer mannheimTINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAYJanuary 9, 1998
K973390ventana medical systemsCHEMMATE L26 (CD20)October 3, 1997
K973389ventana medical systemsCHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAININGOctober 3, 1997
K973391ventana medical systemsCHEMMATE KAPPAOctober 3, 1997
K973392ventana medical systemsCHEMMATE LAMBDAOctober 3, 1997
K965100crestat diagnosticsN-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KITJuly 14, 1997
K964766beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)April 25, 1997
K931979ventana medical systemsVENTANA NEGATIVE CONTROL REAGENTMarch 30, 1994
K920005instrumentation laboratoryIL TEST ALPHA-1-ANTITRYPSIN (AAT)July 29, 1992
K913666binding siteALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KITDecember 9, 1991
K890415atlantic antibodiesSPQ(TM) ANTIBODY REAGENT SET II FOR AATFebruary 17, 1989