Panels › Immunology › Product code DEM · Class 2
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Regulation 866.5130
0510(k)s in 12 months (30 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DEM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2013 | K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS The Binding Site Group , Ltd., GB | DEM |
| Jan 11, 2007 | K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH Dade Behring, Inc. | DEM |
| Mar 28, 2006 | K053072 | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN Dade Behring, Inc. | DEM |
| Dec 23, 2005 | K052819 | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. | DEM |
| May 13, 2005 | K050596 | QUANTIA A1-AT Biokit, S.A., ES | DEM |
| Sep 4, 2003 | K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY Bayer Diagnostics Corp. | DEM |
| Jul 30, 2001 | K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS The Binding Site, Ltd. | DEM |
| May 18, 2001 | K010978 | TINA-QUANT ALPHA-1 ANTITRYPSIN Rochdiag | DEM |
| Nov 24, 1999 | K993444 | K-ASSAY ALPHA-1 AT Kamiya Biomedical Co. | DEM |
| Jan 9, 1998 | K972640 | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY Boehringer Mannheim Corp. | DEM |
| Oct 3, 1997 | K973392 | CHEMMATE LAMBDA Ventana Medical Systems, Inc. | DEM |
| Oct 3, 1997 | K973391 | CHEMMATE KAPPA Ventana Medical Systems, Inc. | DEM |
| Oct 3, 1997 | K973390 | CHEMMATE L26 (CD20) Ventana Medical Systems, Inc. | DEM |
| Oct 3, 1997 | K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING Ventana Medical Systems, Inc. | DEM |
| Jul 14, 1997 | K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT Crestat Diagnostics, Inc. | DEM |
| Apr 25, 1997 | K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) Beckman Instruments, Inc. | DEM |
| Mar 30, 1994 | K931979 | VENTANA NEGATIVE CONTROL REAGENT Ventana Medical Systems, Inc. | DEM |
| Jul 29, 1992 | K920005 | IL TEST ALPHA-1-ANTITRYPSIN (AAT) Instrumentation Laboratory CO | DEM |
| Dec 9, 1991 | K913666 | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd. | DEM |
| Feb 17, 1989 | K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT Atlantic Antibodies | DEM |
| Jul 8, 1988 | K882446 | ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. | DEM |
| Feb 10, 1988 | K875283 | QM2/QM300 CONTROL B PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEM |
| Feb 10, 1988 | K875281 | QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEM |
| Mar 14, 1985 | K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN Applications Lab | DEM |
| Sep 16, 1980 | K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO J.T. Baker Chemical Co. | DEM |
| Sep 4, 1979 | K791605 | GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN Protos Laboratories | DEM |
| Aug 21, 1978 | K781408 | RID SYSTEM-(ACP) TEST Icl Scientific | DEM |
| Feb 3, 1978 | K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT Gelman Instrument Co. | DEM |
| Nov 16, 1976 | K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST Hyland Therapeutic Div., Travenol Laboratories | DEM |
| Aug 11, 1976 | K760034 | TEST, STREP, LATEX SLIDE Gamma Biologicals, Inc. | DEM |
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