Enzymatic Method, Ammonia
FDA product code JIF · Class I (low risk) · 21 CFR 862.1065 · Clinical Chemistry
30510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Abbott Laboratories 3
- Siemens Healthcare Diagnostics, Inc. 2
- Bayer Diagnostics Corp. 2
- Diagnostic Chemicals , Ltd. 2
- Em Diagnostic Systems, Inc. 2
- Beckman Coulter Inc. 2
- Tech Intl. Co. 1
- Roche Diagnostics Operations (Rdo) 1
- Randox Laboratories, Ltd. 1
- Trace America, Inc. 1
- Dade Intl., Inc. 1
- Diagnostic Chemicals, Ltd. (Usa) 1
- Beckman Instruments, Inc. 1
- Sigma Chemical Co. 1
- Roche Diagnostic Systems, Inc. 1
- Baxter Healthcare Corp 1
- Reagents Applications, Inc. 1
- American Dade 1
- Gilford Diagnostics 1
- E.I. Dupont DE Nemours & Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183517 | Ammonia IIJIF · Traditional | Roche Diagnostics Operations (Rdo) | 02/08/2019SE |
| K123677 | Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)JIF · Traditional | Siemens Healthcare Diagnostics | 03/07/2013SE |
| K123320 | Dimension Ammonia Flex Reagent CartridgeJIF · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K062316 | Dimension Vista Ammonia (Amon) Flex Reagent CartridgeJIF · Special | Dade Behring, Inc. | 09/06/2006SE |
| K051114 | Sentinel Ammonia Ultra Diagnostic AssayJIF · Traditional | Sentinel Ch. Srl | 11/25/2005SE |
| K033921 | AMMONIA-L3K Assay, Catalogue Number 233-10JIF · Traditional | Diagnostic Chemicals , Ltd. | 03/10/2004SE |
| K030873 | Randox AmmoniaJIF · Traditional | Randox Laboratories, Ltd. | 05/12/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | Bayer Diagnostics Corp. | 12/24/2002SE |
| K021151 | Ammonia Assay for the Advia Integrated Modular SystemJIF · Traditional | Bayer Diagnostics Corp. | 07/13/2002SE |
| K003196 | Synchron Systems Ammonia ReagentJIF · Traditional | Beckman Coulter, Inc. | 12/22/2000SE |
| K001285 | AMMONIA-L3K Assay, Model 263-17, AMMONIA-L3K Assay, Model 263-30JIF · Traditional | Diagnostic Chemicals , Ltd. | 06/02/2000SE |
| K984402 | Synchron Systems Ammonia (Amm) ReagentJIF · Traditional | Beckman Coulter, Inc. | 01/29/1999SE |
| K981920 | AmmJIF · Traditional | Abbott Laboratories | 07/22/1998SE |
| K981467 | AmmJIF · Traditional | Abbott Laboratories | 06/22/1998SE |
| K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST)JIF · Traditional | Trace America, Inc. | 01/02/1998SE |
| K964565 | Paramax Ammonia and Ammonia Blank ReagentJIF · Traditional | Dade Intl., Inc. | 11/22/1996SE |
| K932556 | Ammonia Assay Cat. No. 200-02JIF · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/02/1994SE |
| K934925 | Beckman Ammonia Amm Reagent/ CX Ammonia CalibratorJIF · Traditional | Beckman Instruments, Inc. | 04/26/1994SE |
| K915707 | Ammonia Reagent SetJIF · Traditional | Tech Intl. Co. | 02/26/1992SE |
| K913124 | Roche Reagent for AmmoniaJIF · Traditional | Roche Diagnostic Systems, Inc. | 08/12/1991SE |
| K880651 | Paramax Ammonia ReagentJIF · Traditional | Baxter Healthcare Corp | 03/24/1988SE |
| K872110 | Easy-Test Ammonia (Amon) Item No. 16695JIF · Traditional | Em Diagnostic Systems, Inc. | 07/01/1987SE |
| K870787 | Abbott Spectrum Ammonia ReagentJIF · Traditional | Abbott Laboratories | 03/31/1987SE |
| K870143 | Ammonia (Amon) Testpack, Item No. 67689/95JIF · Traditional | Em Diagnostic Systems, Inc. | 02/11/1987SE |
| K864706 | Raichem(Tm) Ammonia ReagentJIF · Traditional | Reagents Applications, Inc. | 01/05/1987SE |
| K840770 | Paramax Ammonia ReagenttJIF · Traditional | American Dade | 04/04/1984SE |
| K821719 | Ammonia ReagentJIF · Traditional | Gilford Diagnostics | 06/24/1982SE |
| K770363 | Aca Ammonia Analytical Test PackJIF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/08/1977SE |
| K770273 | Test, Ammonia, BMC ReagentsetJIF · Traditional | Boehringer Mannheim Corp. | 03/01/1977SE |
| K760332 | Sigma Ammonia ReagentJIF · Traditional | Sigma Chemical Co. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2966-2020 Class II | AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro…Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being… | Randox Laboratories, Ltd. | 07/30/2020Terminated |
| Z-2965-2020 Class II | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro…Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being… | Randox Laboratories, Ltd. | 07/30/2020Terminated |
| Z-1655-2018 Class II | Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1649-2018 Class II | Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1646-2018 Class II | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1141-2017 Class II | Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in…Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex… | Siemens Healthcare Diagnostics, Inc. | 12/16/2016Terminated |
| Z-1140-2017 Class II | Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro…Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180… | Siemens Healthcare Diagnostics, Inc. | 12/16/2016Terminated |
| Z-1078-2017 Class II | Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN…Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an… | Sekisui Diagnostics P.E.I. Inc. | 11/29/2016Terminated |
| Z-0164-2016 Class II | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement…Results for ammonia are below the linear range of the assay for samples that have been collected in sodium… | Sentinel CH SpA | 09/22/2015Terminated |
| Z-1432-2012 | SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with…The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on… | Beckman Coulter Inc. | 03/26/2009Terminated |
| Z-0015-2008 | Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro…Method is susceptible to positive interference from endogenous ALT in patient samples. | Thermo Fisher Scientific | 07/24/2007Terminated |