Product code DEM
- Device name
- Alpha-1-Antitrypsin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5130
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | The Binding Site Group , Ltd. | 2013-07-03 |
| K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | 2007-01-11 |
| K053072 | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | Dade Behring, Inc. | 2006-03-28 |
| K052819 | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| K050596 | QUANTIA A1-AT | Biokit, S.A. | 2005-05-13 |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Bayer Diagnostics Corp. | 2003-09-04 |
| K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | The Binding Site, Ltd. | 2001-07-30 |
| K010978 | TINA-QUANT ALPHA-1 ANTITRYPSIN | Rochdiag | 2001-05-18 |
| K993444 | K-ASSAY ALPHA-1 AT | Kamiya Biomedical Co. | 1999-11-24 |
| K972640 | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY | Boehringer Mannheim Corp. | 1998-01-09 |
| K973392 | CHEMMATE LAMBDA | Ventana Medical Systems, Inc. | 1997-10-03 |
| K973391 | CHEMMATE KAPPA | Ventana Medical Systems, Inc. | 1997-10-03 |
| K973390 | CHEMMATE L26 (CD20) | Ventana Medical Systems, Inc. | 1997-10-03 |
| K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | Ventana Medical Systems, Inc. | 1997-10-03 |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 |
| K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | Beckman Instruments, Inc. | 1997-04-25 |
| K931979 | VENTANA NEGATIVE CONTROL REAGENT | Ventana Medical Systems, Inc. | 1994-03-30 |
| K920005 | IL TEST ALPHA-1-ANTITRYPSIN (AAT) | Instrumentation Laboratory CO | 1992-07-29 |
| K913666 | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-09 |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Atlantic Antibodies | 1989-02-17 |
| K882446 | ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 |
| K875281 | QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-02-10 |
| K875283 | QM2/QM300 CONTROL B PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-02-10 |
| K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN | Applications Lab | 1985-03-14 |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | J.T. Baker Chemical Co. | 1980-09-16 |
| K791605 | GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN | Protos Laboratories | 1979-09-04 |
| K781408 | RID SYSTEM-(ACP) TEST | Icl Scientific | 1978-08-21 |
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | Gelman Instrument Co. | 1978-02-03 |
| K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1976-11-16 |
| K760034 | TEST, STREP, LATEX SLIDE | Gamma Biologicals, Inc. | 1976-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700010696 | Human Alpha 1 Antitrypsin NL BINDARID™ Kit | THE BINDING SITE GROUP LIMITED | 2023-06-29 |
| 07613336130230 | Tina-quant a1-Antitrypsin ver.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740156411 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156299 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156374 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740153519 | Alinity | ABBOTT LABORATORIES | 2019-01-04 |
| 00630414596228 | Atellica CH AAT | Siemens Healthcare Diagnostics Inc. | 2017-12-19 |
| 00817302023152 | CLC720 Chemistry Analyzer w/ISE | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-12-19 |
| 00630414517728 | ADVIA® Chemistry AAT Alpha-1-Antitrypsin Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768009938 | N Antiserum to Human a1-Antitrypsin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768009921 | N Antiserum to Human a1-Antitrypsin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768005992 | Dimension Vista®a1-Antitrypsin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 05051700017763 | Optilite Alpha-1-antitrypsin Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 15099590010607 | AU | BECKMAN COULTER IRELAND INC. | 2016-09-24 |
| 05051700016421 | Human alpha 1 antitrypsin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| B1761220 | Antiserum to Alpha 1 Antitrypsin | KENT LABORATORIES INC | 2016-09-24 |
| 04015630928415 | Tinaquant 1Antitrypsin ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630906758 | Tina-quant alpha1-Antitrypsin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630927562 | Albumin BCP | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916597 | Tinaquant 1Antitrypsin ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 00816426020009 | K-ASSAY® Alpha-1 AT Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00380740044862 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740054151 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740030131 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 15099590224042 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750002290 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |