Other products from "ALFA WASSERMANN, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857969006709 404200-1 404200-1 ACE Axcel Clinical Chemistry System with ISE JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ACE Axcel®
2 00857969006600 S2-87 S2-87 Hemoglobin A1c Calibrators JIS Calibrator, Primary 2 Alfa Wassermann
3 00857969006433 C2-87 C2-87 Lipid Controls JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Alfa Wassermann
4 00857969006426 C2-86 C2-86 Hemoglobin A1c Controls JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Alfa Wassermann
5 00857969006402 C1-5 C1-5 Level 2 Chemistry Control JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Alfa Wassermann
6 00857969006396 C1-4 Level 1 Chemistry Control JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Alfa Wassermann
7 00857969006389 SA1029 SA1029 CAL A JIX Calibrator, Multi-Analyte Mixture 2 Alfa Wassermann
8 00857969006372 E1-9 E1-9 STARLYTE V Fluid Pack Alfa Wassermann
9 00857969006327 E1-3 E1-3 REFERENCE ELECTRODE SOLUTION Alfa Wassermann
10 00857969006310 E1-2 E1-2 CAL B Alfa Wassermann
11 00857969006204 S2-86 S2-86 Hemoglobin A1c Calibrators JIS Calibrator, Primary 2 Alfa Wassermann
12 00857969006198 S2-85 S2-85 Urine Standard JIX Calibrator, Multi-Analyte Mixture 2 Alfa Wassermann
13 00857969006181 S1-33 S1-33 GemCal Reference Serum JIX Calibrator, Multi-Analyte Mixture 2 Alfa Wassermann
14 00857969006051 906178 906178 Electrode, Chloride CGZ Electrode, Ion-Specific, Chloride 2 Alfa Wassermann
15 00857969006044 903394 903394 Electrode, Potassium CEM Electrode, Ion Specific, Potassium 2 Alfa Wassermann
16 00857969006037 903393 903393 Electrode, Sodium JGS Electrode, Ion Specific, Sodium 2 Alfa Wassermann
17 00857969006693 402900-1 402900-1 ACE Alera Clinical Chemistry System with ISE JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ACE Alera®
18 00857969006587 SA2019 SA2019 Magnesium Reagent JGJ Photometric Method, Magnesium 1 ACE
19 00857969006594 SA2038 SA2038 HDL-C Reagent LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 ACE
20 00857969006686 RX1053 RX1053 AST Reagent CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 ACE
21 00857969006679 SA1053 SA1053 AST Reagent CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 ACE
22 00857969006662 SA1052 SA1052 ALT Reagent CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1 ACE
23 00857969006655 SA1028 SA1028 ISE CLEANING AND SODIUM ELECTRODE CONDITIONER ACE
24 00857969006648 SA1027 SA1027 ISE WASH ACE
25 00857969006631 SA1021 SA1021 SYSTEM DILUENT ACE
26 00857969006624 SA1020 SA1020 NORMAL SALINE DILUENT ACE
27 00857969006617 SA1050 SA1050 Hemoglobin A1c Reagent LCP Assay, Glycosylated Hemoglobin 2 ACE
28 00857969006570 SA2016 SA2016 Inorganic Phosphorus U.V. Reagent CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1 ACE
29 00857969006563 SA2013 SA2013 γ-GT Reagent JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase 1 ACE
30 00857969006556 SA1046 SA1046 ALT Reagent CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1 ACE
31 00857969006549 SA1045 SA1045 Lipase Reagent CHI Lipase-Esterase, Enzymatic, Photometric, Lipase 1 ACE
32 00857969006532 SA1043 SA1043 HDL-C Reagent LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 ACE
33 00857969006525 SA1040 SA1040 LDL-C Reagent MRR System, Test, Low Density, Lipoprotein 1 ACE
34 00857969006518 SA1025 SA1025 Uric Acid Reagent KNK Acid, Uric, Uricase (Colorimetric) 1 ACE
35 00857969006501 SA1023 SA1023 Triglycerides Reagent CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 ACE
36 00857969006495 SA1017 SA1017 Total Iron Reagent JIY Photometric Method, Iron (Non-Heme) 1 ACE
37 00857969006488 SA1010 SA1010 Cholesterol Reagent CHH Enzymatic Esterase--Oxidase, Cholesterol 1 ACE
38 00857969006471 RX1026 RX1026 LDL-C Reagent MRR System, Test, Low Density, Lipoprotein 1 ACE
39 00857969006464 RX1025 RX1025 Uric Acid Reagent KNK Acid, Uric, Uricase (Colorimetric) 1 ACE
40 00857969006457 RX1023 RX1023 Triglycerides Reagent CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 ACE
41 00857969006440 RX1010 RX1010 Cholesterol Reagent CHH Enzymatic Esterase--Oxidase, Cholesterol 1 ACE
42 00857969006419 C2-85 C2-85 Urine Chemistry Controls JJY Multi-Analyte Controls, All Kinds (Assayed) 1 ACE
43 00857969006365 E1-8 E1-8 Starlyte III Fluid Pack ACE
44 00857969006358 E1-7 E1-7 Urine Diluent ACE
45 00857969006341 E1-6 E1-6 Starlyte Sodium Electrode Conditioner ACE
46 00857969006334 E1-5 E1-5 Starlyte Cleaning Solution ACE
47 00857969006303 SA2002 SA2002 Alkaline Phosphatase Reagent CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 ACE
48 00857969006297 RX2002 RX2002 Alkaline Phosphatase Reagent CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 ACE
49 00857969006280 SA3018 SA3018 LDH-L Reagent CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 ACE
50 00857969006273 SA3007 SA3007 T4 Reagent KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine 2 ACE
Other products with the same Product Code "CDN"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 10758750031788 6844294 6844294 VITROS XT Chemistry Products UREA-CREA Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
2 10758750004980 8479396 8479396 VITROS Chemistry Products CK Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
3 10758750004973 8478034 8478034 VITROS Chemistry Products CK Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
4 10758750004362 8102204 8102204 VITROS Chemistry Products BUN/UREA Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
5 EABA40000411 400-0041 400-0041 The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin 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 AmLyte 13 ABAXIS, INC.
6 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.
7 EABA40000351 400-0035 400-0035 The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid 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 BioChemistry Panel Plus ABAXIS, INC.
8 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.
9 EABA40000331 400-0033 400-0033 The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine 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 Kidney Check ABAXIS, INC.
10 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.
11 EABA40000291 400-0029 400-0029 The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer The Piccolo® General Chemistry 13 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), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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 General Chemistry 13 ABAXIS, INC.
12 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.
13 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.
14 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.
15 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.
16 EABA40000061 400-0006 400-0006 The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyz The Piccolo® General Chemistry 6 , 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), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, 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 General Chemistry 6 ABAXIS, INC.
17 00857969006266 SA2024 SA2024 BUN / UREA Reagent ACE ALFA WASSERMANN, INC.