Other products from "STANBIO LABORATORY, L.P."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00657498300039 G3000-CONTCUV G3000-CONTCUV The HemoPoint® H2 system is intended for the quantitative determination of hemog The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents. GKR System, Hemoglobin, Automated 2 HemoPoint H2
2 00657498002261 7014-204 7014-204 Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood G Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is important to do control solution tests routinely to ensure getting accurate results. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Blood Glucose Control Solution
3 00657498001776 20270479 20270479 For use to wash the ISE module and sample probe. Sirrus® ISE Wash Solution
4 00657498001530 S0370-600 S0370-600 For the Quantitative Colorimetric Determination of Iron in Serum. JIY Photometric Method, Iron (Non-Heme) 1 Sirrus® Total Iron LiquiColor®
5 00657498001509 S0250-750 S0250-750 For the Quantitative Colorimetric Determination of Total Protein in Serum. CEK Biuret (Colorimetric), Total Protein 2 Sirrus® Total Protein LiquiColor®
6 00657498001479 S0190-750 S0190-750 For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. KHS Enzymatic, Carbon-Dioxide 2 Sirrus® Bicarbonate (CO2) LiquiColor®
7 00657498001356 1430-050 1430-050 A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine. JHI Visual, Pregnancy Hcg, Prescription Use TRUE® 20 hCG
8 00657498001141 1012-030 1012-030 Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol i Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma. CHH Enzymatic Esterase--Oxidase, Cholesterol 1 Cholesterol Standard (200 mg/dL)
9 00657498001127 0550-605 0550-605 For use as a multi-calibrator serum to calibrate different chemistry reagent use For use as a multi-calibrator serum to calibrate different chemistry reagent used in manual and automated clinical chemistry methods. JIX Calibrator, Multi-Analyte Mixture 2 Ser-T-Cal Multicalibrator
10 00657498001042 2200-225 2200-225 For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor® (Mono)
11 00657498001035 2200-430 2200-430 For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor® (Mono)
12 00657498000861 2370-401 2370-401 Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for qual Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Glycated Serum Protein Bi-Level Control Set
13 00657498000847 2350-062 2350-062 Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. LCP Assay, Glycosylated Hemoglobin 2 Glycated Serum Protein (GSP) LiquiColor®
14 00657498000533 2460-605 2460-605 For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, an For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate. DIF Drug Mixture Control Materials 1 TDM/B-Hydroxybutyrate Tri-Level Controls
15 00657498000526 B2440-180 B2440-180 For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor®
16 00657498000519 2440-058 2440-058 For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 B-Hydroxybutyrate LiquiColor®
17 00657498000489 2970-430 2970-430 For the Quantitative Determination of Amylase in Serum and Urine. JFJ Catalytic Methods, Amylase 2 a-Amylase LiquiColor®
18 00657498000120 202000 202000 STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 STAT-Site Diluent
19 00657498000014 6300-020 6300-020 For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. LYR Helicobacter Pylori RELY® H.Pylori
20 00657498301654 3016-050 3016-050 For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. GKR System, Hemoglobin, Automated HemoPoint® H2 n•x•t Microcuvettes
21 00657498001837 S0130-600 S0130-600 For the Quantitative Determination of Magnesium in Serum, Plasma or Urine. JGJ Photometric Method, Magnesium 1 Sirrus® Magnesium LiquiColor®
22 00657498001561 S0590-540 S0590-540 For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 Sirrus® Direct HDL Cholesterol LiquiColor®
23 00657498001523 S0360-200 S0360-200 For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. LCP Assay, Glycosylated Hemoglobin 2 Sirrus® Direct Gylcohemoglobin (HbA1c)
24 00657498001486 S0230-600 S0230-600 For the Quantitative Colorimetric Determination of Total Bilirubin in Serum and Plasma. JFM Enzymatic Method, Bilirubin 2 Sirrus® Total Bilirubin LiquiColor®
25 00657498001318 1230-025 1230-025 For the qualitative determination of human chorionic gonadotropin (hCG) in serum For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. JHI Visual, Pregnancy Hcg, Prescription Use QuPID® Plus hCG Pregnancy Test
26 00657498001301 1170-500 1170-500 Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. GMQ Antigens, Nontreponemal, All 2 RPR Quicktest
27 00657498001295 1170-100 1170-100 Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. GMQ Antigens, Nontreponemal, All 2 RPR Quicktest
28 00657498001219 G428-86 G428-86 Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Ser-T-Fy 2, Level 2 Control
29 00657498001066 2100-225 2100-225 For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor®
30 00657498001059 2100-430 2100-430 For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor®
31 00657498000809 1060-500 1060-500 For the Quantitative Determination of Glucose in Serum or Plasma. CFR Hexokinase, Glucose 2 Glucose Liqui-UV®
32 00657498000632 0210-250 0210-250 Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF. CHJ Mercuric Thiocyanate, Colorimetry, Chloride 2 Chloride LiquiColor®
33 00657498000236 3025-050 3025-050 For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. GKR System, Hemoglobin, Automated n•x•t Microcuvette
34 00657498000168 503000 503000 A bi-level reference control intended for use on STAT-Site® and HemoSite® hemogl A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. JPK Mixture, Hematology Quality Control 2 STAT-Site Hgb Controls
35 00657498000113 303500 303500 The STAT-Site® Linearity Check is intended to be used to perform a linearity eva The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 STAT-Site Linearity Check
36 00657498002377 3063-006 3063-006 A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 HGB Controls - High
37 00657498002360 3063-003 3063-003 A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 HGB Controls - High
38 00657498002216 7010-100 7010-100 The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. LFR Glucose Dehydrogenase, Glucose STAT-Site WB Blood Glucose Test Strips
39 00657498002209 7010-050 7010-050 The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. LFR Glucose Dehydrogenase, Glucose STAT-Site WB Blood Glucose Test Strips
40 00657498002193 7010-025 7010-025 The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. LFR Glucose Dehydrogenase, Glucose STAT-Site WB Blood Glucose Test Strips
41 00657498002131 4000-100 4000-100 Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Nitro-tab Ketone Tablets
42 00657498002025 3060-101N 3060-101N A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Hgb Control, Normal
43 00657498001905 20270476 20270476 Ion-Selective Electrode for the measurement of potassium in serum. CEM Electrode, Ion Specific, Potassium 2 ISE Potassium Electrode
44 00657498001790 A469-98 A469-98 To provide calibration points for the Sodium, Potassium, and Chloride electrodes To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems. JIX Calibrator, Multi-Analyte Mixture 2 Standard 2
45 00657498001752 20270477 20270477 The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium. JIX Calibrator, Multi-Analyte Mixture 2 Sirrus® ISE Calibrator 1
46 00657498001745 2211-600 2211-600 For use as a probe cleaner on the Sirrus® Chemistry Analyzer. Sirrus® Probe Cleaner
47 00657498001639 S2200-750 S2200-750 For the Quantitative Colorimetric Determination of Triglycerides in Serum and Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Sirrus® Triglyceride LiquiColor®
48 00657498001615 S1060-600 S1060-600 For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine. CFR Hexokinase, Glucose 2 Sirrus® Glucose Liqui-UV®
49 00657498001257 1130-100 1130-100 Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. DCN System, Test, C-Reactive Protein 2 RaPET® CRP
50 00657498001240 1130-050 1130-050 Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. DCN System, Test, C-Reactive Protein 2 RaPET® CRP
Other products with the same Product Code "CKA"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 15099590625672 476826 476826 Alanine Aminotransferase Reagent (ALT 2 x 400) Synchron BECKMAN COULTER, INC.
2 15099590575205 442620 442620 Alanine Aminotransferase Reagent (ALT 2 x 200) Synchron BECKMAN COULTER, INC.
3 15099590575090 467840 467840 Alanine Aminotransferase Reagent (ALT- 2 x 300) Synchron BECKMAN COULTER, INC.
4 15099590575083 467848 467848 Alanine Aminotransferase Reagent (ALT- 2 x 100) Synchron BECKMAN COULTER, INC.
5 15099590060022 OSR6607 ALT AU BECKMAN COULTER, INC.
6 15099590010065 OSR6107 ALT AU BECKMAN COULTER, INC.
7 10758750032136 6844288 6844288 VITROS Chemistry Products ALTV Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
8 10758750031757 6844291 6844291 VITROS XT Chemistry Products ALTV-AST Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
9 10758750009480 1655281 1655281 VITROS Chemistry Products ALT Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
10 07613336120989 08056773190 08056773190 Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation ROCHE DIAGNOSTICS GMBH
11 05060500091712 UV185-1200 UV185-1200 ALT Reagent 8 X 67 mL + 2 X 67 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
12 05060500090227 UV182-L UV182-L ALT Starter Reagent 6 X 500 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
13 05060500090210 UV184-L UV184-L ALT Substrate Reagent 6 X 500 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
14 05060500090203 UV185-911 UV185-911 ALT Reagent 4 X 50 mL + 1 X 50 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
15 05060500090197 UV185-WK UV185-WK ALT Reagent 4 X 25 mL + 4 X 6.25 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
16 05060500090180 UV185-X UV185-X ALT Reagent 1 X 100 mL + 1 X 25 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
17 05060500090173 UV185-R UV185-R ALT Reagent 4 X 100 mL + 1 X 100 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
18 05055273208160 AL8304 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
19 05055273208153 AL8006 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
20 05055273200249 AL7930 AL7930 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
21 05055273200232 AL7904 AL7904 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
22 05055273200225 AL3875 AL3875 An ALT test system is a device intended for the quantitative in vitro determinat An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and plasma. ALT RANDOX LABORATORIES LIMITED
23 05055273200218 AL3801 AL3801 An ALT test system is a device intended for the quantitative in vitro determinat An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma. ALT RANDOX LABORATORIES LIMITED
24 05055273200195 AL2360 AL2360 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
25 05055273200188 AL146 AL146 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
26 05055273200171 AL1268 AL1268 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
27 05055273200164 AL1205 AL1205 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
28 05055273200157 AL1200 AL1200 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
29 05055273200133 AL100 AL100 ALANINE AMINOTRANSFERASE (ALT) RANDOX LABORATORIES LIMITED
30 04015630928927 5850797190 5850797190 Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation ROCHE DIAGNOSTICS GMBH
31 04015630927425 5531462190 5531462190 Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP ROCHE DIAGNOSTICS GMBH
32 04015630921973 4718569190 4718569190 Alanine aminotransferase acc. IFCC with or without PYP ROCHE DIAGNOSTICS GMBH
33 04015630920532 4467388190 4467388190 Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation ROCHE DIAGNOSTICS GMBH
34 04015630913862 20764957322 20764957322 Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation ROCHE DIAGNOSTICS GMBH
35 03610230006856 1300023832 Yumizen C1200 AST HORIBA ABX SAS
36 03610230006801 1300023797 Yumizen C1200 ALT HORIBA ABX SAS
37 03610230004906 1220001627 ABX PENTRA ALT CP HORIBA ABX SAS
38 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.
39 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.
40 EABA40000301 400-0030 400-0030 The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.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 (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. Piccolo Lipid Panel Plus ABAXIS, INC.
41 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.
42 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.
43 EABA40000261 400-0026 400-0026 The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry ana The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitroquantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, directbilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratorysetting or point-of-care location. Piccolo Hepatic Function Panel ABAXIS, INC.
44 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.
45 EABA40000031 400-0003 400-0003 The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, utilizes dry and liquid reagents to provide in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and total protein 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 Liver Panel Plus ABAXIS, INC.
46 00857969006662 SA1052 SA1052 ALT Reagent ACE ALFA WASSERMANN, INC.
47 00857969006556 SA1046 SA1046 ALT Reagent ACE ALFA WASSERMANN, INC.
48 00852169008034 ALT1020 ALT1020 In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL ClearChem Diagnostics Inc. Alanine aminotransferase (ALT) CLEARCHEM DIAGNOSTICS INC.
49 00842768034336 10475530 DF143 Alanine Aminotransferase Flex® reagent cartridge, 240 tests Dimension® Flex® reagent cartridge ALTI SIEMENS HEALTHCARE DIAGNOSTICS INC.
50 00842768034312 10635565 K2143 Alanine Aminotransferase Flex® reagent cartridge, 480 tests Dimension Vista® Flex® reagent cartridge ALTI SIEMENS HEALTHCARE DIAGNOSTICS INC.