Enzymatic, Carbon-Dioxide
FDA product code KHS · 85 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1160
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-01 – 2017-06-01
KHS
2017-06-01
KHS
2016-02-24
Liquid CO2-2 (LCO2-2)
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KHS
2013-10-09
AU BICARBONATE REAGENT
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KHS
2013-05-02
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
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KHS
2012-10-24
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
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KHS
2012-07-02
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
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KHS
2011-11-18
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
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KHS
2010-12-15
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
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KHS
2010-05-10
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
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KHS
2010-04-15
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
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KHS
2009-07-13
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
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KHS
2008-06-26
S-TEST C02
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KHS
2007-10-05
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
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KHS
2007-04-30
CARBON DIOXIDE LIQUID STABLE REAGENT
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KHS
2006-07-21
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
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KHS
2006-05-25
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
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KHS
2006-05-04
CARBON DIOXIDE
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KHS
2004-12-27
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
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KHS
2003-08-21
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
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KHS
2003-07-17
COBAS INTEGRA CARBON DIOXIDE ASSAY
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KHS
2001-09-06
JAS CARBON DIOXIDE LIQUID REAGENT
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KHS
2001-05-21
ANALYST PANELS + ANALYTICAL TEST ROTOR
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KHS
2001-03-16
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
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KHS
2000-09-26
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
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KHS
2000-04-24
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
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KHS
1999-09-15
CARESIDE CO2, TOTAL
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KHS
1999-05-25
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
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KHS
1999-04-20
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
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KHS
1998-09-14
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
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KHS
1998-06-24
RAICHEM CO2 REAGENT
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KHS
1998-06-08
CO2
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KHS
1998-06-05
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
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KHS
1998-05-12
CO2
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KHS
1996-04-08
CARBON DIOXIDE - DST
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KHS
1996-03-11
SYNERMED ENZYMATIC CO2 REAGENT KIT
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KHS
1996-02-29
SERUM BICARBONATE/CARBON DIOXIDE
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KHS
1996-02-15
TOTAL CO2
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KHS
1995-10-05
CARBON DIOXIDE - DST
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KHS
1995-03-20
CARBON DIOXIDE (C02)
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KHS
1994-12-05
BOEHRINGER MANNHEIM BICARBONATE ASSAY
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KHS
1994-04-26
TECHNISON AXON SYSTEM
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KHS
1993-09-24
ENZYMATIC CO2 REAGENT, MODIFICATION
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KHS
1993-08-03
BICARBONATE
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KHS
1992-12-03
BICARBONATE
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KHS
1992-12-03
SYNERMED ENZYMATIC CO2 REAGENT KIT
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KHS
1991-11-27
COULTER CARBON DIOXIDE REAGENT
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KHS
1991-09-11
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
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KHS
1990-10-04
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
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KHS
1990-09-27
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
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KHS
1990-09-25
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
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KHS
1990-09-13
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
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KHS
1990-06-12
COULTER CARBON DIOXIDE REAGENT
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KHS
1990-02-23
CARBON DIOXIDE REAGENT
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KHS
1990-02-13
CO2 REAGENT (340 NM)
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KHS
1990-02-01
CARBON DIOXIDE REAGENT
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KHS
1989-12-21
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
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KHS
1989-09-15
BICARBONATE TEST ITEM NUMBER: 65412
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KHS
1989-06-09
BICARBONATE; SYSTEM PACK REAGENTS
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KHS
1989-02-17
BICARBONATE TEST ITEM NUMBER: SR1006
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KHS
1988-12-27
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
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KHS
1988-11-01
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
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KHS
1988-08-30
DART CARBON DIOXIDE
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KHS
1988-08-02
ENZYMATIC CO2 REAGENT SET
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KHS
1988-06-15
BICARBONATE (CO2) REAGENT-2 VIAL
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KHS
1988-04-28
CARBON DIOXIDE REAGENT
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KHS
1988-04-28
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
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KHS
1988-04-18
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
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KHS
1988-03-16
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
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KHS
1988-03-15
CO2 REAGENT
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KHS
1988-01-05
BIOTROL BICARBONATE (CO2) UV HP)
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KHS
1987-11-23
BICARBONATE
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KHS
1987-06-17
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
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KHS
1987-02-13
BICARBONATE PROCEDURE
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KHS
1986-09-29
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
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KHS
1986-07-01
BICARBONATE PROCEDURE
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KHS
1985-12-13
RAICHEM CO2 REAGENT
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KHS
1985-04-08
DATA ZYME CO2 PROCEDURE
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KHS
1985-01-18
ROCHE REAGENTS REAGENT FOR CO2
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KHS
1984-06-08
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
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KHS
1984-06-07
DEMAND C02
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KHS
1984-04-04
CARBON DIOXIDE REAGENT
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KHS
1982-07-27
ENZYMATIC CO2
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KHS
1981-02-23
BICARBONATE TEST
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KHS
1977-10-25
MULTISTAT III BICARBONATE TEST
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KHS
1976-11-01
REAGENT KIT, ENZYMATIC CO2
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