Alpha-1-Antitrypsin, Antigen, Antiserum, Control
FDA product code DEM · Class II (moderate risk) · 21 CFR 866.5130 · Immunology
30510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Ventana Medical Systems, Inc. 5
- The Binding Site, Ltd. 2
- Dade Behring, Inc. 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Gelman Instrument Co. 1
- Hyland Therapeutic Div., Travenol Laboratories 1
- The Binding Site Group , Ltd. 1
- Bayer Diagnostics Corp. 1
- Rochdiag 1
- Kamiya Biomedical Co. 1
- Boehringer Mannheim Corp. 1
- Crestat Diagnostics, Inc. 1
- Beckman Instruments, Inc. 1
- Protos Laboratories 1
- Instrumentation Laboratory CO 1
- Gamma Biologicals, Inc. 1
- Atlantic Antibodies 1
- Technicon Instruments Corp. 1
- Icl Scientific 1
- Applications Lab 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123256 | Human ALPHA-1 Antitrypsin Kit SpaplusDEM · Traditional | The Binding Site Group , Ltd. | 07/03/2013SE |
| K063610 | Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…DEM · Traditional | Dade Behring, Inc. | 01/11/2007SE |
| K053072 | N Antisera to Human ALPHA1-ANTITRYPSINDEM · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…DEM · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/23/2005SE |
| K050596 | Quantia A1-ATDEM · Traditional | Biokit, S.A. | 05/13/2005SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | Bayer Diagnostics Corp. | 09/04/2003SE |
| K011663 | Minineph A-1 Antitrypsin Antiserum, High and Low Serum ControlsDEM · Traditional | The Binding Site, Ltd. | 07/30/2001SE |
| K010978 | Tina-Quant ALPHA-1 AntitrypsinDEM · Traditional | Rochdiag | 05/18/2001SE |
| K993444 | K-Assay ALPHA-1 atDEM · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K972640 | Tina-Quant Alpha PARTICLE-1-ANTITRYPSIN AssayDEM · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K973392 | Chemmate LambdaDEM · Traditional | Ventana Medical Systems, Inc. | 10/03/1997SE |
| K973391 | Chemmate KappaDEM · Traditional | Ventana Medical Systems, Inc. | 10/03/1997SE |
| K973390 | Chemmate L26 (CD20)DEM · Traditional | Ventana Medical Systems, Inc. | 10/03/1997SE |
| K973389 | Chemmate UCHL1 (CD45RO) Prediluted Antibody for Immunohistochemical StainingDEM · Traditional | Ventana Medical Systems, Inc. | 10/03/1997SE |
| K965100 | N-Assay Tia ALPHA-1-ANTITRYPSIN Test KitDEM · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964766 | Immage Immunochemistry System ALPHA-1-ANTITRYPSIN (Aat)DEM · Traditional | Beckman Instruments, Inc. | 04/25/1997SE |
| K931979 | Ventana Negative Control ReagentDEM · Traditional | Ventana Medical Systems, Inc. | 03/30/1994SE |
| K920005 | Il Test ALPHA-1-ANTITRYPSIN (Aat)DEM · Traditional | Instrumentation Laboratory CO | 07/29/1992SE |
| K913666 | ALPHA-1-ANTITRYPSIN Immunological NL Test KitDEM · Traditional | The Binding Site, Ltd. | 12/09/1991SE |
| K890415 | Spq(Tm) Antibody Reagent Set II for AatDEM · Traditional | Atlantic Antibodies | 02/17/1989SE |
| K882446 | ALPHA1ANTITRYPSIN for Technicon DPA-1(TM) SystemDEM · Traditional | Technicon Instruments Corp. | 07/08/1988SE |
| K875283 | QM2/QM300 Control B PackDEM · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 02/10/1988SE |
| K875281 | QM300 ALPHA1-ANTITRYPSIN Antibody PackDEM · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 02/10/1988SE |
| K850587 | SPQ Test System for Alpha, - AntitrypsinDEM · Traditional | Applications Lab | 03/14/1985SE |
| K801669 | J.T. Baker ALPHA-1-ANTITRYPSIN NepheloDEM · Traditional | J.T. Baker Chemical Co. | 09/16/1980SE |
| K791605 | Goat Anti-Human ALPHA-1-ANTITRYPSINDEM · Traditional | Protos Laboratories | 09/04/1979SE |
| K781408 | Rid System-(Acp) TestDEM · Traditional | Icl Scientific | 08/21/1978SE |
| K772080 | Radial Immunodiffusion Kit-Alph-L-AntitDEM · Traditional | Gelman Instrument Co. | 02/03/1978SE |
| K760916 | Las-R Human Alpha, Antitrypsin TestDEM · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 11/16/1976SE |
| K760034 | Test, Strep, Latex SlideDEM · Traditional | Gamma Biologicals, Inc. | 08/11/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0002-2018 Class II | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The…The high control for the kit is recovering low and may be out of range for assigned values. | The Binding Site Group, Ltd. | 08/23/2017Terminated |