Enzymatic, Carbon-Dioxide
FDA product code KHS · Class II (moderate risk) · 21 CFR 862.1160 · Clinical Chemistry
86510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Em Diagnostic Systems, Inc. 7
- Boehringer Mannheim Corp. 4
- Diagnostic Chemicals , Ltd. 4
- Abbott Laboratories 4
- Data Medical Associates, Inc. 4
- Pointe Scientific, Inc., 3
- Ortho-Clinical Diagnostics 3
- Trace America, Inc. 3
- Diagnostic Chemicals, Ltd. (Usa) 3
- Roche Diagnostic Systems, Inc. 2
- Reagents Applications, Inc. 2
- Dade Behring, Inc. 2
- Teco Diagnostics 2
- Technicon Instruments Corp. 2
- Roche Diagnostics Corp. 2
- Intersect Systems, Inc. 2
- American Monitor Corp. 2
- Synermed, Inc. 2
- Coulter Corp. 2
- Randox Laboratories, Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | Teco Diagnostics, Inc. | 06/01/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | Randox Laboratories, Ltd. | 02/24/2016SE |
| K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2)KHS · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/11/2014SE |
| K131546 | Au Bicarbonate ReagentKHS · Traditional | Beckman Coulter Ireland, Inc. | 10/09/2013SE |
| K123953 | Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent…KHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 05/02/2013SE |
| K120765 | Vitros Chemistry Products ECO2 SlidesKHS · Special | Ortho-Clinical Diagnostics, Inc. | 10/24/2012SE |
| K113435 | Ace Carbon DIOXIDE(CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…KHS · Traditional | Alfa Wassermann | 07/02/2012SE |
| K111960 | Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…KHS · Traditional | Elitechgroup | 11/18/2011SE |
| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 12/15/2010SE |
| K100289 | Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781KHS · Traditional | Siemens Healthcare Diagnostics | 05/10/2010SE |
| K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…KHS · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/15/2010SE |
| K091153 | Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291KHS · Traditional | Beckman Coulter, Inc. | 07/13/2009SE |
| K073223 | S-Test C02KHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/26/2008SE |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and AbtrolKHS · Traditional | Thermofisher Scientific OY | 10/05/2007SE |
| K070251 | Carbon Dioxide Liquid Stable ReagentKHS · Traditional | Pointe Scientific, Inc., | 04/30/2007SE |
| K060619 | Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122AKHS · Traditional | Diazyme Laboratories | 07/21/2006SE |
| K061238 | Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…KHS · Special | Dade Behring, Inc. | 05/25/2006SE |
| K060295 | Carbon DioxideKHS · Traditional | Abbott Laboratories | 05/04/2006SE |
| K042362 | Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…KHS · Traditional | Diagnostic Chemicals , Ltd. | 12/27/2004SE |
| K032377 | Roche Diagnostics Hitachi Bicarbonate LiquidKHS · Special | Roche Diagnostics Corp. | 08/21/2003SE |
| K031879 | Cobas Integra Carbon Dioxide AssayKHS · Special | Roche Diagnostics Corp. | 07/17/2003SE |
| K012332 | Jas Carbon Dioxide Liquid ReagentKHS · Traditional | Jas Diagnostics, Inc. | 09/06/2001SE |
| K010864 | Analyst Panels + Analytical Test RotorKHS · Traditional | Hemagen Diagnostics, Inc. | 05/21/2001SE |
| K010206 | Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137KHS · Traditional | Dade Behring, Inc. | 03/16/2001SE |
| K002354 | Carbon DIOXIDE-L3K-C Assay, Models 288-30 and 288-80KHS · Traditional | Diagnostic Chemicals , Ltd. | 09/26/2000SE |
| K001133 | Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2KHS · Special | Ortho-Clinical Diagnostics, Inc. | 04/24/2000SE |
| K992475 | Careside CO2, TotalKHS · Traditional | Careside, Inc. | 09/15/1999SE |
| K991108 | Carbon Dioxide (CO2), Product No. CC0107-01KHS · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K990754 | Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50KHS · Traditional | Diagnostic Chemicals , Ltd. | 04/20/1999SE |
| K983019 | Carbon Dioxide-Sl Assay, Cat # 253-01KHS · Traditional | Diagnostic Chemicals , Ltd. | 09/14/1998SE |
| K982056 | Raichem CO2 ReagentKHS · Special | Reagents Applications, Inc. | 06/24/1998SE |
| K981840 | CO2KHS · Traditional | Abbott Laboratories | 06/08/1998SE |
| K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)KHS · Traditional | Roche Diagnostic Systems, Inc. | 06/05/1998SE |
| K981231 | CO2KHS · Traditional | Abbott Mfg., Inc. | 05/12/1998SE |
| K960035 | Carbon Dioxide - DSTKHS · Traditional | Trace America, Inc. | 04/08/1996SE |
| K960793 | Synermed Enzymatic CO2 Reagent KitKHS · Traditional | Synermed, Inc. | 03/11/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | Data Medical Associates, Inc. | 02/29/1996SE |
| K951221 | Total CO2KHS · Traditional | Randox Laboratories, Ltd. | 02/15/1996SE |
| K952410 | Carbon Dioxide - DSTKHS · Traditional | Trace America, Inc. | 10/05/1995SE |
| K942735 | Carbon Dioxide (C02)KHS · Traditional | Teco Diagnostics | 03/20/1995SE |
| K933461 | Boehringer Mannheim Bicarbonate AssayKHS · Traditional | Boehringer Mannheim Corp. | 12/05/1994SE |
| K941156 | Technison Axon SystemKHS · Traditional | Miles, Inc. | 04/26/1994SE |
| K932267 | Enzymatic CO2 Reagent, ModificationKHS · Traditional | Intersect Systems, Inc. | 09/24/1993SE |
| K931887 | BicarbonateKHS · Traditional | Em Diagnostic Systems, Inc. | 08/03/1993SE |
| K924711 | BicarbonateKHS · Traditional | Em Diagnostic Systems, Inc. | 12/03/1992SE |
| K924428 | Synermed Enzymatic CO2 Reagent KitKHS · Traditional | Synermed, Inc. | 12/03/1992SE |
| K914486 | Coulter Carbon Dioxide ReagentKHS · Traditional | Coulter Corp. | 11/27/1991SE |
| K912806 | Abbott Quickstart Bicarbonate Test CO2 Item# 5A22KHS · Traditional | Em Diagnostic Systems, Inc. | 09/11/1991SE |
| K903409 | Systemate Bicarbonate Olympus BicarbonateKHS · Traditional | Em Diagnostic Systems, Inc. | 10/04/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | Technicon Instruments Corp. | 09/27/1990SE |
| K903144 | Kodak Ektachem Clinical Chemistry Slides (ECO2)KHS · Traditional | Eastman Kodak Company | 09/25/1990SE |
| K904007 | Bicarbonate Reagents Amresco Product #4326020KHS · Traditional | Amresco, Inc. | 09/13/1990SE |
| K902229 | Coulter Carbon Dioxide ReagentKHS · Traditional | Coulter Corp. | 06/12/1990SE |
| K896812 | Carbon Dioxide ReagentKHS · Traditional | Pointe Scientific, Inc., | 02/23/1990SE |
| K896258 | CO2 Reagent (340 NM)KHS · Traditional | Sigma Chemical Co. | 02/13/1990SE |
| K896590 | Carbon Dioxide ReagentKHS · Traditional | Pointe Scientific, Inc., | 02/01/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | Catachem, Inc. | 12/21/1989SE |
| K894509 | Bicarbonate Test Item Number: 65412KHS · Traditional | Em Diagnostic Systems, Inc. | 09/15/1989SE |
| K891991 | Bicarbonate; System Pack ReagentsKHS · Traditional | Boehringer Mannheim Corp. | 06/09/1989SE |
| K890305 | Bicarbonate Test Item Number: SR1006KHS · Traditional | Em Diagnostic Systems, Inc. | 02/17/1989SE |
| K884821 | Abbott Spectrum(R) Bicarbonate ReagentKHS · Traditional | Abbott Laboratories | 12/27/1988SE |
| K880868 | Carbon Dioxide Assay Kit (Enzymatic) 201-18/202-18KHS · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 11/01/1988SE |
| K883055 | Dart Carbon DioxideKHS · Traditional | Coulter Electronics, Inc. | 08/30/1988SE |
| K882497 | Enzymatic CO2 Reagent SetKHS · Traditional | American Monitor Corp. | 08/02/1988SE |
| K881938 | Bicarbonate (CO2) REAGENT-2 VialKHS · Traditional | Trace Scientific , Ltd. | 06/15/1988SE |
| K881169 | Carbon Dioxide ReagentKHS · Traditional | Intersect Systems, Inc. | 04/28/1988SE |
| K880866 | Carbon Dioxide Assay Kit(Enzy. Single) 203-10KHS · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 04/28/1988SE |
| K880794 | Resubmitted Bicarbonate (CO2) Reagent Single VialKHS · Traditional | Trace America, Inc. | 04/18/1988SE |
| K880609 | Analyte Carbon Dioxide Assayed on Technicon Ra(Tm)KHS · Traditional | Technicon Instruments Corp. | 03/16/1988SE |
| K880268 | CO2 ReagentKHS · Traditional | Sigma Diagnostics, Inc. | 03/15/1988SE |
| K874941 | Biotrol Bicarbonate (CO2) UV HP)KHS · Traditional | Biotrol, USA, Inc. | 01/05/1988SE |
| K874435 | BicarbonateKHS · Traditional | Boehringer Mannheim Corp. | 11/23/1987SE |
| K872108 | Abbott Spectrum Bicarbonate Reagent KitKHS · Traditional | Abbott Laboratories | 06/17/1987SE |
| K870062 | Bicarbonate ProcedureKHS · Traditional | Data Medical Associates, Inc. | 02/13/1987SE |
| K863544 | Easy-Test Carbon Dioxide (CO2) Item #67649/95KHS · Traditional | Em Diagnostic Systems, Inc. | 09/29/1986SE |
| K861673 | Bicarbonate ProcedureKHS · Traditional | Data Medical Associates, Inc. | 07/01/1986SE |
| K854544 | Raichem CO2 ReagentKHS · Traditional | Reagents Applications, Inc. | 12/13/1985SE |
| K850903 | Data Zyme CO2 ProcedureKHS · Traditional | Data Medical Associates, Inc. | 04/08/1985SE |
| K844987 | Roche Reagents Reagent for CO2KHS · Traditional | Roche Diagnostic Systems, Inc. | 01/18/1985SE |
| K841664 | Enzymatic CO2 Diagnostic ChemicalKHS · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 06/08/1984SE |
| K841726 | Demand C02KHS · Traditional | Cooper Biomedical, Inc. | 06/07/1984SE |
| K840773 | Carbon Dioxide ReagentKHS · Traditional | American Dade | 04/04/1984SE |
| K822079 | Enzymatic CO2KHS · Traditional | American Monitor Corp. | 07/27/1982SE |
| K810356 | Bicarbonate TestKHS · Traditional | Boehringer Mannheim Corp. | 02/23/1981SE |
| K771507 | Multistat III Bicarbonate TestKHS · Traditional | Instrumentation Laboratory CO | 10/25/1977SE |
| K760546 | Reagent Kit, Enzymatic CO2KHS · Traditional | Beckman Instruments, Inc. | 11/01/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0997-2026 Class II | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system…Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate… | Beckman Coulter Ireland, Inc. | 10/14/2025Open, Classified |
| Z-0510-2024 Class II | VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry…Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598… | Ortho-Clinical Diagnostics, INc. | 10/25/2023Open, Classified |
| Z-1608-2023 Class II | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mLThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in… | Beckman Coulter Inc. | 04/05/2023Open, Classified |
| Z-1607-2023 Class II | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mLThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in… | Beckman Coulter Inc. | 04/05/2023Open, Classified |
| Z-1606-2023 Class II | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mLThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in… | Beckman Coulter Inc. | 04/05/2023Open, Classified |
| Z-0575-2020 Class II | Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I.…Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the… | Abbott GmBH & Co. KG | 10/23/2019Terminated |
| Z-0312-2014 Class II | VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |