No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05055273207071 | CPL4017 | DDB | Ceruloplasmin, Antigen, Antiserum, Control | 2 | CERULOPLASMIN (CPL) | ||
2 | 05055273203400 | GR2368 | KQF | Assay, Glutathione Reductase | 2 | GLUTATHIONE REDUCTASE (GLUT RED) | ||
3 | 05055273209587 | UP8113 | JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | TOTAL PROTEIN (UP) | ||
4 | 05055273207118 | LUN5048 | OHQ | Multi-Analyte Controls Unassayed | 1 | LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2) | ||
5 | 05055273207163 | LUL5093 | OHQ | Multi-Analyte Controls Unassayed | 1 | LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1) | ||
6 | 05055273204322 | LO3999 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
7 | 05055273203516 | GY1369 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GLYCEROL CONTROL (GLY CONTROL) | ||
8 | 05055273203066 | FA115 | JLG | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids | 1 | Non-Esterified Fatty Acids (NEFA) | ||
9 | 05055273200164 | AL1205 | AL1205 | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ALANINE AMINOTRANSFERASE (ALT) | |
10 | 05055273217766 | AMH10516 | AMH10516 | The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AMH CONTROL LEVEL 4 (AMH CONTROL 4) |
11 | 05055273217667 | CQ10430 | CQ10430 | This product is intended for in vitro use, in the quality control of Cardiac Mar This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) |
12 | 05055273215205 | LE10175 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) | ||
13 | 05055273215175 | BR10172 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) | ||
14 | 05055273214338 | RX4045 | RX4045 | This is required for measuring reference electrode potential of an ion selective This is required for measuring reference electrode potential of an ion selective electrode module. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | REF SOLN |
15 | 05055273214307 | RP8398 | RP8398 | The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RABS |
16 | 05055273213966 | CH2656 | Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma. | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | |
17 | 05055273210378 | RX8106 | RX8106 | Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ANTI-BACTERIAL DETERGENT (Detergent) |
18 | 05055273209389 | SA8396 | SA8396 | This product should be used in conjunction with RX daytona plus reagents to dilu This product should be used in conjunction with RX daytona plus reagents to dilute samples prior to assay. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NS |
19 | 05055273209211 | LP8007 | MSJ | Apolipoproteins | 1 | APOLIPOPROTEIN A-I (APO A-I) | ||
20 | 05055273209204 | LP5047 | JIT | Calibrator, Secondary | 2 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | ||
21 | 05055273209181 | LO8305 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
22 | 05055273209174 | LO8015 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
23 | 05055273209143 | LM4005 | LM4005 | The product is intended for the quantitative in vitro determination of Lithium in serum. | NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 2 | Li 2 |
24 | 05055273209020 | LAN4216 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 2 (LIQ CHEM ASY PREMIUM 2) | ||
25 | 05055273208634 | CR8316 | CR8316 | The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine | CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | CREA |
26 | 05055273208498 | CH8312 | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | ||
27 | 05055273208481 | CH8311 | For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | |
28 | 05055273208467 | CH8033 | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | ||
29 | 05055273208450 | CH8032 | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | ||
30 | 05055273208412 | CH1383 | Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | |
31 | 05055273208047 | DA4011 | DA4011 | The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-qu The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine. | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | BZG |
32 | 05055273207958 | DA3127 | DA3127 | The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Cont The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | THC CONTROL 1 |
33 | 05055273207330 | IAS3118 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. Thismaterial can be used to monitor the control of accuracy or the control of reproducibility of immunoassays. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | IMMUNOASSAY SPECIALITY II - LEVEL 2 (IA SPECIALITY II LEV 2) | |
34 | 05055273207880 | DA2704 | DA2704 | The Randox Multidrug Calibrator Set is intended for use in the calibration of Me The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays. | DKB,DLJ | Calibrators, Drug Mixture,Calibrators, Drug Specific | 2 | DOA CAL |
35 | 05055273207866 | DA2702 | DA2702 | The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. | DKB | Calibrators, Drug Mixture | 2 | EDDP CAL |
36 | 05055273207781 | RX4041 | RX4041 | The Randox RX daytona plus without ISE is a fully automated, random access, clin The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RX daytona plus |
37 | 05055273207774 | RX4040 | RX4040 | The Randox RX daytona plus with ISE is a fully automated, random access, clinica The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RX daytona plus |
38 | 05055273207644 | CG5023 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) | ||
39 | 05055273207262 | IA3110 | This product is intended for in vitro diagnostic use, as assayed quality control This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2) | |
40 | 05055273207248 | LIA3108 | The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays statedin this package insert. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3) | |
41 | 05055273206456 | TD3414 | TD3414 | For the quantitative in vitro determination of Valproic Acid in human serum | LEG | Enzyme Immunoassay, Valproic Acid | 2 | VPA |
42 | 05055273206173 | SE1086 | OHQ | Multi-Analyte Controls Unassayed | 1 | BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3) | ||
43 | 05055273206111 | SA3854 | SA3854 | This product should be used in conjunction with RX series reagents to dilute sam This product should be used in conjunction with RX series reagents to dilute samples prior to assay | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | NS |
44 | 05055273205091 | RP3857 | RP3857 | The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | RABS |
45 | 05055273204315 | LO3998 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
46 | 05055273204049 | IT2692 | IT2692 | Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution. | JIX | Calibrator, Multi-Analyte Mixture | 2 | SP CAL (LIQ) |
47 | 05055273204032 | IT2691 | IT2691 | Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays. | JIX | Calibrator, Multi-Analyte Mixture | 2 | SP CAL (LIQ) |
48 | 05055273203783 | HN1530 | The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target valu The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR | |
49 | 05055273202458 | EV3550 | EV3550 | Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. | DKB | Calibrators, Drug Mixture | 2 | DOA CAL |
50 | 05055273202397 | EV3542 | EV3542 | The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays. | DIO,DJR,DKZ,DIS,JXM,LDJ,DJG,LCM | Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadon Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Phencyclidine | 2 | DOA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05055273213959 | CD8357 | CD8357 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | LCO2-2 | RANDOX LABORATORIES LIMITED |
2 | 05055273208375 | CD4006 | CD4006 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | LCO2-2 | RANDOX LABORATORIES LIMITED |
3 | 05055273201086 | CD7942 | CD7942 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
4 | 05055273201031 | CD129 | CD129 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
5 | 05055273201024 | CD127 | CD127 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
6 | 05055273201017 | CD116 | CD116 | The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. | CO2 | RANDOX LABORATORIES LIMITED |
7 | 04015630997237 | 3607402190 | 3607402190 | Bircarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
8 | 04015630935673 | 5446376191 | 5446376191 | BicarbonateBicarbonate STAT | ROCHE DIAGNOSTICS GMBH | |
9 | 04015630927395 | 5455308190 | 5455308190 | Bircarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
10 | 04015630919376 | 3289885190 | 3289885190 | Bicarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
11 | 04015630919369 | 3289907190 | 3289907190 | Bicarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
12 | 04015630919352 | 3289923190 | 3289923190 | Bicarbonate liquid | ROCHE DIAGNOSTICS GMBH | |
13 | 03610230006863 | 1300023833 | Yumizen C1200 CO2 | HORIBA ABX SAS | ||
14 | 03610230005071 | 1220001645 | ABX PENTRA CO2 RTU | HORIBA ABX SAS | ||
15 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
16 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo MetLyte Plus CRP | ABAXIS, INC. |
17 | EABA40000311 | 400-0031 | 400-0031 | The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. |
18 | EABA40000281 | 400-0028 | 400-0028 | The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. |
19 | EABA40000271 | 400-0027 | 400-0027 | The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Renal Function Panel | ABAXIS, INC. |
20 | EABA40000241 | 400-0024 | 400-0024 | The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Basic Metabolic Panel | ABAXIS, INC. |
21 | EABA40000231 | 400-0023 | 400-0023 | The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo MetLyte 8 Panel | ABAXIS, INC. |
22 | EABA40000221 | 400-0022 | 400-0022 | The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Electrolyte Panel | ABAXIS, INC. |
23 | 00857969006150 | SA2039 | SA2039 | Carbon Dioxide Reagent | ACE | ALFA WASSERMANN, INC. |
24 | 00852169008072 | CAR1090 | CAR1090 | In Vitro Diagnostics testing kit R1:6X30mL | ClearChem Diagnostics Inc. Carbon Dioxide (CO2) | CLEARCHEM DIAGNOSTICS INC. |
25 | 00845275000047 | TR28321 | Thermo Scientific Infinity™ | FISHER DIAGNOSTICS | ||
26 | 00842768015625 | 10445163 | K1137 | Carbon Dioxide Flex® reagent cartridge, 3360 Tests | Dimension Vista® Flex® reagent cartridge CO2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
27 | 00842768005374 | 10444972 | DF137 | Enzymatic Carbonate Flex® reagent cartridge, 360 tests | Dimension® Flex® reagent cartridge EC02 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
28 | 00817302022988 | DT313 | DT313 | CO2 (Carbon Dioxide) 4 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CO2 REAGENT PRODUCT NO. DT313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
29 | 00817302022049 | AU-313 | AU-313 | CO2 (Carbon Dioxide) w/ cal 3 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT AU-313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
30 | 00817302022032 | ST313 | ST313 | CO2 (Carbon Dioxide) w/ cal 4 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CO2 RGT KIT Product No. ST313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
31 | 00817302022025 | BL313 | BL313 | CO2 (Carbon Dioxide) w/ cal 3 x 140 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
32 | 00817274022498 | CO23-125 | C023-125 | CARBON DIOXIDE LIQUID 405nm (2x 125mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
33 | 00817274021118 | XL-CO23-20 | CARBON DIOXIDE LIQUID 405nm (6x 20mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
34 | 00812137011947 | 120mL | 501-407 | For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | Carbon Dioxide Reagent | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
35 | 00811727016102 | 16-C7502-180 | 16-C7502-180 | Pointe Carbon Dioxide Reagent packaged for use on the Mindray BA800. 4 x 45ml. Pointe Carbon Dioxide Reagent packaged for use on the Mindray BA800. 4 x 45ml. For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | Pointe Carbon Dioxide Reagent | POINTE SCIENTIFIC, INC. |
36 | 00811727015792 | 14-C7502-160 | 14-C7502-160 | Pointe Carbon Dioxide packaged for use on the BS480 analyzer. 4x40mL Kit. For t Pointe Carbon Dioxide packaged for use on the BS480 analyzer. 4x40mL Kit. For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | Pointe Carbon Dioxide on the BS480 | POINTE SCIENTIFIC, INC. |
37 | 00811727014979 | OC702-180 | OC702-180 | Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determina Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determination of Carbon Dioxide in serum, packaged for use on Olympus analyzers. For in vitro diagnostic use only.4 x 45ml | Pointe Scientific, Inc. Carbon Dioxide | POINTE SCIENTIFIC, INC. |
38 | 00811727013453 | 12-C7502-160 | 12-C7502-160 | For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC CO2 | POINTE SCIENTIFIC, INC. |
39 | 00811727012630 | HC702-180 | HC702-180 | Carbon Dioxide Liquid Reagent, for the quantitative determination of Carbon Diox Carbon Dioxide Liquid Reagent, for the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use. 4 x 45mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
40 | 00811727012623 | HC702-400 | HC702-400 | Carbon Dioxide, Liquid Stable Reagent Set for the quantitative determination of Carbon Dioxide, Liquid Stable Reagent Set for the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. Packaged at 8 x 50ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
41 | 00811727012616 | HC702-200 | HC702-200 | Carbon Dioxide, Liquid Stable Reagent Set for the quantitative determination of Carbon Dioxide, Liquid Stable Reagent Set for the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. Packaged at 10 x 20ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
42 | 00811727010698 | C7504-STD | C7504-STD | Intended for use as an carbon dioxide standard for standardization or calibratio Intended for use as an carbon dioxide standard for standardization or calibration of PECP / NADH analog carbon dioxide procedures. | POINTE SCIENTIFIC Carbon Dioxide Standard | POINTE SCIENTIFIC, INC. |
43 | 00811727010681 | C7502-1L | C7502-1L | For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable | POINTE SCIENTIFIC, INC. |
44 | 00811727010674 | C7502-480 | C7502-480 | For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable | POINTE SCIENTIFIC, INC. |
45 | 00811727010667 | C7502-120 | C7502-120 | For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Carbon Dioxide, Liquid Stable | POINTE SCIENTIFIC, INC. |
46 | 00657498001479 | S0190-750 | S0190-750 | For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. | Sirrus® Bicarbonate (CO2) LiquiColor® | STANBIO LABORATORY, L.P. |
47 | 00630414595900 | 11097521 | 11097521 | Carbon dioxide (CO2_c) Atellica CH - RGT 7600T | Atellica CH CO2_c | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00630414553177 | 10283345 | 6860507 | CO2 enzymatic - ADVIA Chem. - Conc. RGT - 7520 tests | ADVIA® Chemistry CO2_c Reagents Concentrated | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00630414505497 | 10326480 | 7506781 | CO2 enzymatic - ADVIA Chem. - RGT - 1200 tests | ADVIA® Chemistry CO2_L Carbon Dioxide Liquid Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00630414498928 | 10327377 | 7987100 | CO2 enzymatic - ADVIA Chem. - RGT - 4x600 tests | ADVIA® Chemistry CO2_L Reagents (Liquid) | SIEMENS HEALTHCARE DIAGNOSTICS INC. |