Nadh Oxidation/Nad Reduction, Ast/Sgot
FDA product code CIT · Class II (moderate risk) · 21 CFR 862.1100 · Clinical Chemistry
139510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Em Diagnostic Systems, Inc. 10
- Abbott Laboratories 8
- Roche Diagnostic Systems, Inc. 6
- American Monitor Corp. 5
- Coulter Electronics, Inc. 4
- Sigma Diagnostics, Inc. 4
- Trace Scientific , Ltd. 4
- Boehringer Mannheim Corp. 3
- Amresco, Inc. 3
- Data Medical Associates, Inc. 3
- Diagnostic Chemicals, Ltd. (Usa) 3
- The Dow Chemical Co. 3
- Harleco 3
- Wako Chemicals USA, Inc. 3
- Gilford Diagnostics 2
- Sigma Chemical Co. 2
- Smithkline Diagnostics, Inc. 2
- Union Carbide Corp. 2
- Beckman Instruments, Inc. 2
- Pointe Scientific, Inc., 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093883 | Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model ASSL-0250…CIT · Traditional | Seppim S.A.S. | 09/20/2010SE |
| K080485 | Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSCIT · Traditional | Diasys Diagnostics Systems GmbH | 12/04/2008SE |
| K071525 | Activated Aspartate AminotransferaseCIT · Traditional | Abbott Laboratories | 03/19/2008SE |
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional | Thermofisher Scientific OY | 10/03/2007SE |
| K071211 | Cobas C 111 AnalyzerCIT · Traditional | Roche Diagnostics | 07/30/2007SE |
| K060318 | Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerCIT · Traditional | Horiba Abx | 08/08/2006SE |
| K023551 | Wiener Lab Got (Ast) UV Aa LiquidaCIT · Traditional | Wiener Laboratories Saic | 12/09/2002SE |
| K013698 | Ast (Sgot)CIT · Traditional | Jas Diagnostics, Inc. | 12/21/2001SE |
| K013145 | Wiener Lab. Got (Ast) UV Aa. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat.…CIT · Traditional | Wiener Laboratories Saic | 11/27/2001SE |
| K010488 | Atac Pak Ast Reagent KitCIT · Traditional | Elan Holdings, Inc. | 04/09/2001SE |
| K001679 | Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3CIT · Special | Ortho-Clinical Diagnostics, Inc. | 06/28/2000SE |
| K993468 | Wako L-Type Got TestCIT · Traditional | Wako Chemicals USA, Inc. | 12/16/1999SE |
| K992136 | Bayer Advia Integrated Modular System (Ims)CIT · Traditional | Bayer Corp. | 11/09/1999SE |
| K992801 | Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast…CIT · Traditional | Sigma Diagnostics, Inc. | 09/28/1999SE |
| K991663 | Ast/SgotCIT · Traditional | A.P. Total Care, Inc. | 06/30/1999SE |
| K990009 | Careside AstCIT · Traditional | Careside, Inc. | 03/16/1999SE |
| K983131 | AstCIT · Traditional | Abbott Laboratories | 09/28/1998SE |
| K981843 | AstCIT · Traditional | Abbott Laboratories | 06/29/1998SE |
| K981650 | Ast/Sgot Liquid Reagent - Kinetic MethodCIT · Traditional | Teco Diagnostics | 06/29/1998SE |
| K981225 | Aspartate Aminotransferase (Ast)CIT · Traditional | Abbott Laboratories | 04/23/1998SE |
| K981221 | Aspartate Aminotransferase Activated ( Ast Activated)CIT · Traditional | Abbott Laboratories | 04/23/1998SE |
| K980902 | N-Assay L Ast/GotCIT · Traditional | Crestat Diagnostics, Inc. | 03/26/1998SE |
| K980666 | Infinity Ast Reagent (Procedure No. 51)CIT · Traditional | Sigma Diagnostics, Inc. | 03/20/1998SE |
| K980030 | Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CIT · Traditional | Trace America, Inc. | 01/30/1998SE |
| K974001 | Aspartate Aminotransferase-Sl Assay, Catalogue Number 319-10, 319-30CIT · Traditional | Diagnostic Chemicals , Ltd. | 11/13/1997SE |
| K971344 | Ast or SgotCIT · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
| K965126 | Ast/SgotCIT · Traditional | Derma Media Lab., Inc. | 01/17/1997SE |
| K961114 | Ast Incorporating DSTCIT · Traditional | Trace Scientific , Ltd. | 05/23/1996SE |
| K954992 | Roche Cobas Integra Reagent CassettesCIT · Traditional | Roche Diagnostic Systems, Inc. | 01/25/1996SE |
| K954839 | Aspartate Aminotransferase Procedure No.. 58-UVCIT · Traditional | Sigma Diagnostics, Inc. | 01/05/1996SE |
| K952743 | Aspartate Aminotransferase Reagent SystemCIT · Traditional | Medical Diagnostic Technologies, Inc. | 09/29/1995SE |
| K951751 | Hichem Ast Reagent KitCIT · Traditional | Hichem Diagnostics | 08/02/1995SE |
| K944102 | Ast QvetCIT · Traditional | Prisma Systems | 12/13/1994SE |
| K941132 | Liquid Ast (Sgot)Reagent SetCIT · Traditional | Pointe Scientific, Inc., | 05/02/1994SE |
| K934413 | Kodak Ektachem Clinical Chemistry Slide for Asparate AmimotransferaseCIT · Traditional | Eastman Kodak Company | 04/25/1994SE |
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | Em Diagnostic Systems, Inc. | 01/27/1994SE |
| K932049 | Stanbio Ast/Got (Liqui-Uv) Test Set, Cat No. 9020CIT · Traditional | Stanbio Laboratory | 11/16/1993SE |
| K925155 | Olympus Aspartate Aminotransferase ReagentCIT · Traditional | Olympus Corp. | 01/26/1993SE |
| K924244 | Roche Reagent for AstCIT · Traditional | Roche Diagnostic Systems, Inc. | 01/04/1993SE |
| K923505 | Ast (Got) - Aspartate AminotransferaseCIT · Traditional | Randox Laboratories, Ltd. | 11/16/1992SE |
| K923641 | Il Test Ast, PN 35312CIT · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
| K922857 | Systamate Aspartate Aminotransferase Test TechnicoCIT · Traditional | Em Diagnostic Systems, Inc. | 09/09/1992SE |
| K922885 | Olympus Aspartate Aminotransferase ReagentCIT · Traditional | Olympus Corp. | 07/28/1992SE |
| K922108 | King Diagnostics Ast (Got) ReagentCIT · Traditional | King Diagnostics, Inc. | 07/15/1992SE |
| K920336 | Miles Aspartate Aminotransferase Sera-Pak MethodCIT · Traditional | Heraeus Kulzer, Inc. | 03/04/1992SE |
| K915555 | Synermed Ast/Got Reagent KitCIT · Traditional | Synermed, Inc. | 01/27/1992SE |
| K914463 | Abbott Quickstart Sgot, Item Number: 5A42CIT · Traditional | Em Diagnostic Systems, Inc. | 01/03/1992SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | Technicon Instruments Corp. | 11/22/1991SE |
| K914068 | Abbott Quickstart Asparate Aminotransferase TestCIT · Traditional | Em Diagnostic Systems, Inc. | 10/02/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | Coulter Electronics, Inc. | 02/26/1991SE |
| K903829 | Ast ReagentCIT · Traditional | Amresco, Inc. | 09/25/1990SE |
| K903197 | Aspartate Aminotransferase TestCIT · Traditional | Em Diagnostic Systems, Inc. | 08/17/1990SE |
| K901104 | Paramax Aspartate Aminotransferase ReagentCIT · Traditional | Baxter Healthcare Corp | 03/23/1990SE |
| K897165 | Coulter Ast (Got) ReagentCIT · Traditional | Coulter Electronics, Inc. | 02/23/1990SE |
| K896233 | Cobas Ready Liver Profile Reagent StripCIT · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K896229 | Cobas Ready Profile 1 Reagent StripCIT · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K896228 | Cobas Ready Cardio Profile Reagent StripCIT · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K896000 | Aspartate Aminotranferase (Ast)CIT · Traditional | American Monitor Corp. | 01/11/1990SE |
| K894180 | Abbott Ast-Activated (Liquid, LIST#01A54)CIT · Traditional | Abbott Laboratories | 09/13/1989SE |
| K893692 | Emds Aspartate Aminotransferase Item Number 65405CIT · Traditional | Diagnostic Systems | 08/21/1989SE |
| K892844 | Ast Reagent (Procedure Number 158)CIT · Traditional | Sigma Chemical Co. | 06/20/1989SE |
| K891468 | Ast (Got) Ifcc 2-VIAL Reagent W/Pyridoxyl PhosphatCIT · Traditional | Trace Scientific , Ltd. | 05/22/1989SE |
| K884724 | Aspartate Aminotransferase (Ast)CIT · Traditional | Catachem, Inc. | 03/08/1989SE |
| K885156 | Clinistat Sgot (Ast) Reagent TestCIT · Traditional | Heraeus Kulzer, Inc. | 02/02/1989SE |
| K884377 | Aspartate Aminotransferase Test Item No. 65654CIT · Traditional | Em Diagnostic Systems, Inc. | 12/14/1988SE |
| K880692 | Aspartate Aminotransferase Assay Kit (Ifcc)CIT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 05/27/1988SE |
| K880276 | Ast (Sgot) Reagent SetCIT · Traditional | Tech-Neal Scientific, Inc. | 03/03/1988SE |
| K875071 | Aspartate Aminotransferase Ast/SgotCIT · Traditional | Tech-Co, Inc. | 02/18/1988SE |
| K874600 | Easy-Test Aspartate Aminotransferase (Asat) #19010CIT · Traditional | Em Diagnostic Systems, Inc. | 01/21/1988SE |
| K872829 | Biotrol Ast/Tgo MonoreactifCIT · Traditional | Biotrol, USA, Inc. | 08/13/1987SE |
| K871780 | Ultraviolet Aspartate Amino-Trans (Uv-Ast/Uv-Got)CIT · Traditional | Biochemical Trade, Inc. | 06/04/1987SE |
| K870077 | Aspartate Aminotransferase (Ast)/(Got)CIT · Traditional | Catachem, Inc. | 03/06/1987SE |
| K870246 | Reflotron(R) Ast (Got)CIT · Traditional | Boehringer Mannheim Corp. | 02/18/1987SE |
| K864813 | Wako (TM) Autokit Got TestCIT · Traditional | Wako Chemicals USA, Inc. | 02/13/1987SE |
| K864357 | Ast(Got) (Aspartate Aminotransferase) ReagentCIT · Traditional | Trace Scientific , Ltd. | 02/06/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | J. D. Assoc. | 01/13/1987SE |
| K864302 | Wako(Tm) Got II - HaCIT · Traditional | Wako Chemicals USA, Inc. | 12/16/1986SE |
| K863963 | Emds(Tm) Aspartate Aminotransferase (Ast) 67657/95CIT · Traditional | Em Diagnostic Systems, Inc. | 11/28/1986SE |
| K863257 | Ast/Got ProcedureCIT · Traditional | Data Medical Associates, Inc. | 09/26/1986SE |
| K863094 | Systemate (TM) Alanine Transferase (Alt)CIT · Traditional | Em Diagnostic Systems, Inc. | 08/29/1986SE |
| K862832 | Model 303-42/303-43 Aspartate Aminotransferase KitCIT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/12/1986SE |
| K861656 | Ast/Got ProcedureCIT · Traditional | Data Medical Associates, Inc. | 05/29/1986SE |
| K860465 | Vision Sgot (Ast) - Addit. of Whole Blood ClaimCIT · Traditional | Abbott Laboratories | 05/05/1986SE |
| K861283 | Ast Reagent CartridgeCIT · Traditional | Hi Chem, Inc. | 04/28/1986SE |
| K860725 | Ast(Got) (Aspartate Aminotransferase) ReagentCIT · Traditional | Trace Scientific , Ltd. | 04/07/1986SE |
| K860667 | Aspartate Aminotransferase (Ast/Sgot) Reagent SetCIT · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K854982 | Vision Sgot (Ast)CIT · Traditional | Abbott Laboratories | 01/14/1986SE |
| K854503 | Ast(Optimized) ReagentCIT · Traditional | Sigma Diagnostics, Inc. | 11/25/1985SE |
| K852783 | Sgot/Alt ReagentCIT · Traditional | Advanced Biomedical Methods, Inc. | 07/22/1985SE |
| K851994 | Ast Aspartate Aminotransferase ReagentCIT · Traditional | Alpkem Corp. | 06/03/1985SE |
| K851865 | Amresco Flow Pac Sma Phosphate Buffer ConcentrateCIT · Traditional | Amresco, Inc. | 05/20/1985SE |
| K851267 | Gemeni Ast-Lts ReagentsCIT · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/29/1985SE |
| K843109 | Roche Reagent for AstCIT · Traditional | Roche Diagnostic Systems, Inc. | 11/05/1984SE |
| K843333 | Systemate Got 67208CIT · Traditional | Em Diagnostic Systems, Inc. | 09/20/1984SE |
| K842521 | Ast/Got Reagent Set UV RateCIT · Traditional | Sterling Biochemical, Inc. | 08/12/1984SE |
| K842411 | Sigma 58-UV Aspartate AminotransferasCIT · Traditional | Sigma Chemical Co. | 08/12/1984SE |
| K842245 | Aspartate Aminotransferase Assay KitCIT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/18/1984SE |
| K841066 | Sgot-Uv Reagent SetCIT · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K840706 | Aspartate Aminotransferase ReagentCIT · Traditional | American Dade | 04/04/1984SE |
| K830958 | Flow-Pac Sgot ReagentCIT · Traditional | Amresco, Inc. | 05/04/1983SE |
| K822493 | Optimized Uv-Got Reagent SetCIT · Traditional | Biorent Diagnostic, Inc. | 09/21/1982SE |
| K821208 | Sgot-Uv Reagent SetCIT · Traditional | Omega Medical Electronics | 07/20/1982SE |
| K821876 | Ultrazyme Plus GotCIT · Traditional | Harleco Diagnostics | 07/13/1982SE |
| K821433 | Beckman Liquid-Stat Ast-Uv LiquidCIT · Traditional | Beckman Instruments, Inc. | 06/02/1982SE |
| K821467 | Ultrazyme Plus Got, #64953,65033&65034CIT · Traditional | Emd Chemicals, Inc. | 06/01/1982SE |
| K820270 | Raichem Got (Ast) ReagentCIT · Traditional | Reagents Applications, Inc. | 02/18/1982SE |
| K813405 | Ast(Sgot) in Vitro Diag. Reagent SetCIT · Traditional | Pointe Scientific, Inc., | 12/22/1981SE |
| K812592 | Ultra Zyme Plus Got #64953, 65033 & 34CIT · Traditional | Harleco | 09/24/1981SE |
| K802447 | Got Isoenzyme Assay Eiken KitCIT · Traditional | Syn-Kit, Inc. | 04/17/1981SE |
| K810727 | Ast-Uv (Plp-Activated) DeterminationCIT · Traditional | The Dow Chemical Co. | 03/31/1981SE |
| K810390 | Ast (UV) TestCIT · Traditional | Boehringer Mannheim Corp. | 02/23/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | Union Carbide Corp. | 01/09/1981SE |
| K801856 | Data-Zyme Ast(Got) ProcedureCIT · Traditional | Data Medical Associates, Inc. | 09/16/1980SE |
| K801118 | Cobas Reagent for Ast (Sgot)CIT · Traditional | Roche Analytical Instruments, Inc. | 06/20/1980SE |
| K800688 | Reagent for Determ. Glutamic-OxaloaceticCIT · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K800641 | Centrifi Chem Ast/SgotCIT · Traditional | Union Carbide Corp. | 04/10/1980SE |
| K800116 | Durazyme Got/AstCIT · Traditional | American Monitor Corp. | 02/13/1980SE |
| K800065 | Asi ReagentCIT · Traditional | Gilford Diagnostics | 02/05/1980SE |
| K792208 | Durazyme Got/AstCIT · Traditional | American Monitor Corp. | 11/27/1979SE |
| K791679 | Nadh Oxidation, Ast/SgotCIT · Traditional | American Monitor Corp. | 09/24/1979SE |
| K791080 | Plus Chem S.C.E. ReagentCIT · Traditional | Smithkline Diagnostics, Inc. | 07/24/1979SE |
| K791082 | Spin Chem Reagent, Determination of AstCIT · Traditional | Smithkline Diagnostics, Inc. | 07/17/1979SE |
| K790483 | Coulter Accu-Zyme II Got ReagentCIT · Traditional | Coulter Electronics, Inc. | 05/03/1979SE |
| K790017 | Serum, Glutamic-OxaloaceticCIT · Traditional | Fisher Scientific Co., LLC | 02/26/1979SE |
| K781784 | AstCIT · Traditional | Gilford Diagnostics | 01/03/1979SE |
| K781725 | Reagent Set, U.V. Enzmatic Kinetic, SgotCIT · Traditional | Medical Analysis Systems, Inc. | 11/03/1978SE |
| K781020 | (Ast) or (Alt) UV Determ. Phy. Phos.CIT · Traditional | The Dow Chemical Co. | 07/27/1978SE |
| K780634 | Single Vial 10 Sgot-TrisCIT · Traditional | Boehringer Mannheim Corp. | 05/18/1978SE |
| K780463 | Ast(Got) Uni-Uv, SgotCIT · Traditional | Sclavo, Inc. | 05/12/1978SE |
| K780505 | Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional | Gamma Enterprises, Inc. | 05/03/1978SE |
| K780443 | Sgot/Ast Reagent SystemCIT · Traditional | American Monitor Corp. | 04/24/1978SE |
| K780103 | Ultrazyme Plus GotCIT · Traditional | Harleco | 02/13/1978SE |
| K780039 | Aspartate TransaminaseCIT · Traditional | Beckman Instruments, Inc. | 01/31/1978SE |
| K780013 | Serum Glutamic Oxaloacetic TransaminaseCIT · Traditional | Macomb Chemical Co. | 01/30/1978SE |
| K772029 | Gemsaec Appli, for Ultrazyme Plus GotCIT · Traditional | Harleco | 11/15/1977SE |
| K771153 | Dyna Zyme II Got 340CIT · Traditional | J.T. Baker Chemical Co. | 11/03/1977SE |
| K770318 | Reagent Got, EnzymeCIT · Traditional | Icn Pharmaceuticals, Inc. | 04/05/1977SE |
| K760193 | NDC#12739-0011-1 C-Zyme GotCIT · Traditional | Coulter Electronics, Inc. | 08/03/1976SE |
| K760010 | Colorimetric Determination (Sgot/Sgpt)CIT · Traditional | The Dow Chemical Co. | 07/26/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0199-2024 Class II | RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R…RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample… | Randox Laboratories Ltd. | 09/06/2023Open, Classified |
| Z-1657-2018 Class II | Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148)…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1651-2018 Class II | Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr:…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-0006-2015 Class III | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of…Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality… | ELITech Clinical Systems SAS | 08/11/2014Terminated |
| Z-1530-2014 Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For…Extremely low absorbance readings. | Alfa Wassermann, Inc. | 03/05/2014Terminated |
| Z-0299-2014 Class II | VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0632-2013 Class II | ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic…Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the… | Horiba Instruments, Inc dba Horiba Medical | 10/10/2012Terminated |
| Z-2116-2017 Class III | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE…A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is… | Medtest Holdings, Inc. | 02/15/2012Terminated |
| Z-0172-2009 | AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no.…The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure… | Pointe Scientific, Inc. | 08/25/2008Terminated |
| Z-0171-2009 | Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in…The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure… | Pointe Scientific, Inc. | 08/25/2008Terminated |
| Z-1447-2012 | ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate…This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results… | Abbott Laboratories Inc. | 06/30/2008Terminated |