| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00852169008256 | TRG1400 | TRG1400 | In Vitro Diagnostics testing kit R1:4X60mL | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | 1 | ClearChem Diagnostics Inc. Triglycerides |
| 2 | 00852169008232 | ITI1160 | ITI1160 | In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | ClearChem Diagnostics Inc. TIBC-Direct |
| 3 | 00852169008072 | CAR1090 | CAR1090 | In Vitro Diagnostics testing kit R1:6X30mL | KHS | ENZYMATIC, CARBON-DIOXIDE | 2 | ClearChem Diagnostics Inc. Carbon Dioxide (CO2) |
| 4 | 00852169008270 | MAL1010 | MAL1010 | In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL | JIT,DDZ | Calibrator, secondary,ALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL | 2 | ClearChem Diagnostics Inc. MicroAlbumin |
| 5 | 00852169008225 | PHO1300 | PHO1300 | In Vitro Diagnostics testing kit R1:4X60mL | CEO | Phosphomolybdate (colorimetric), inorganic phosphorus | 1 | ClearChem Diagnostics Inc. Inorganic Phosphorous |
| 6 | 00852169008096 | BRD1050 | BRD1050 | In Vitro Diagnostics testing kit R1:3X28mL, R2:3X7mL | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | ClearChem Diagnostics Inc. Bilirubin, Direct |
| 7 | 00852169008089 | CPK1110 | CPK1110 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | CGS | NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES | 2 | ClearChem Diagnostics Inc. Creatine Kinase (CK) |
| 8 | 00852169008041 | AMY1030 | AMY1030 | In Vitro Diagnostics testing kit R1:3X60mL | CIJ | SACCHAROGENIC, AMYLASE | 2 | ClearChem Diagnostics Inc. Amylase |
| 9 | 00852169008249 | TPR1310 | TPR1310 | In Vitro Diagnostics testing kit R1:4X60mL | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ClearChem Diagnostics Inc. Protein, Total |
| 10 | 00852169008188 | IRN1150 | IRN1150 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X12mL | JIY | Photometric method, iron (non-heme) | 1 | ClearChem Diagnostics Inc. Iron |
| 11 | 00852169008157 | CHL1100 | CHL1100 | In Vitro Diagnostics testing kit R1:4X60mL | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | ClearChem Diagnostics Inc. Cholesterol, Total |
| 12 | 00852169008126 | CRE1120 | CRE1120 | In Vitro Diagnostics testing kit R1:3X50mL, R2:3X10mL | CGX | ALKALINE PICRATE, COLORIMETRY, CREATININE | 2 | ClearChem Diagnostics Inc. Creatinine (Jaffe) |
| 13 | 00852169008102 | BRB1060 | BRB1060 | In Vitro Diagnostics testing kit R1:3X42mL, R2:3X11mL | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | ClearChem Diagnostics Inc. Bilirubin, Total |
| 14 | 00852169008195 | LDH1170 | LDH1170 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | ClearChem Diagnostics Inc. Lactate Dehydogenase (LDH) |
| 15 | 00852169008171 | CRP1320 | CRP1320 | In Vitro Diagnostics testing kit R1:1X20mL, R2:1X20mL | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | 2 | ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP) |
| 16 | 00852169008140 | GLU1140 | GLU1140 | In Vitro Diagnostics testing kit R1:4X60mL | CFR | HEXOKINASE, GLUCOSE | 2 | ClearChem Diagnostics Inc. Glucose |
| 17 | 00852169008010 | ALB1000 | ALB1000 | In Vitro Diagnostics testing R1: 4X60mL | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | 2 | ClearChem Diagnostics Inc. Albumin |
| 18 | 00852169008058 | AST1040 | AST1040 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ClearChem Diagnostics Inc. Aspartate aminotransferase (AST) |
| 19 | 00852169008027 | ALP1010 | ALP1010 | In Vitro Diagnostics testing kit R1:3X48mL, R2:3X12mL | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) |
| 20 | 00852169008263 | URA1500 | URA1500 | In Vitro Diagnostics testing kit R1:5X30mL | KNK | Acid, uric, uricase (colorimetric) | 1 | ClearChem Diagnostics Inc. Uric Acid |
| 21 | 00852169008218 | MAG1180 | MAG1180 | In Vitro Diagnostics testing kit R1:4X30mL, R2:4X30mL | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ClearChem Diagnostics Inc. Magnesium |
| 22 | 00852169008201 | LDL1230 | LDL1230 | In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL | LBR | Ldl & Vldl Precipitation, Hdl | 1 | ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol |
| 23 | 00852169008119 | CAL1080 | CAL1080 | In Vitro Diagnostics testing kit R1:4X60mL | CIC | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | 2 | ClearChem Diagnostics Inc. Calcium |
| 24 | 00852169008294 | MPN2020 | MPN2020 | In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL | JGP,JIX | LOWRY (COLORIMETRIC), TOTAL PROTEIN,Calibrator, multi-analyte mixture | 2 | ClearChem Diagnostics Inc. MicroProtein, Total |
| 25 | 00852169008287 | HGB1200 | HGB1200 | In Vitro Diagnostics testing kit Buffer:1X36mL, R1a:1X16mL, R2b:1X6.7mL, R2:1X10.1mL | LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | ClearChem Diagnostics Inc. Hemoglobin A-1c |
| 26 | 00852169008133 | GGT1130 | GGT1130 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | JQB | KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT) |
| 27 | 00852169008065 | BUN1070 | BUN1070 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | 2 | ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN) |
| 28 | 00852169008034 | ALT1020 | ALT1020 | In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ClearChem Diagnostics Inc. Alanine aminotransferase (ALT) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
| 2 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
| 3 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
| 4 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |
| 5 | 15099590193218 | A15625 | A15625 | HDL Cholesterol Reagent HDL 2 x 200 | Synchron | BECKMAN COULTER, INC. |
| 6 | 15099590020361 | OSR6296 | LDL-Cholesterol | AU | BECKMAN COULTER, INC. | |
| 7 | 15099590020354 | OSR6295 | HDL-Cholesterol | AU | BECKMAN COULTER, INC. | |
| 8 | 15099590010928 | OSR6196 | LDL-Cholesterol | AU | BECKMAN COULTER, INC. | |
| 9 | 15099590010911 | OSR6195 | HDL-Cholesterol | AU | BECKMAN COULTER, INC. | |
| 10 | 10758750002825 | 6802469 | 6802469 | VITROS Chemistry Products dHDL Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 11 | 10758750001668 | 6801895 | 6801895 | VITROS Chemistry Products dHDL Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 12 | 07613336121306 | 08057877190 | 08057877190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
| 13 | 05060500091989 | IR056-1200 | IR056-1200 | HDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 14 | 05060500090838 | IR056-WK | IR056-WK | HDL-Cholesterol Reagent 1 X 25 mL + 1 X 8.4 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 15 | 05060500090821 | IR056-X | IR056-X | HDL-Cholesterol Reagent 1 X 60 mL + 1 X 20 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 16 | 05060500090814 | IR056-R | IR056-R | HDL-Cholesterol Reagent 1 X 240 mL + 1 X 80 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 17 | 05055273208481 | CH8311 | For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. | DIRECT HDL-CHOLESTEROL (HDL) | RANDOX LABORATORIES LIMITED | |
| 18 | 05055273208467 | CH8033 | DIRECT HDL-CHOLESTEROL (HDL) | RANDOX LABORATORIES LIMITED | ||
| 19 | 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. | DIRECT HDL-CHOLESTEROL (HDL) | RANDOX LABORATORIES LIMITED | |
| 20 | 05055273201291 | CH3811 | CH3811 | An HDL-cholesterol test system is a device intended for the quantitative in vitr An HDL-cholesterol test system is a device intended for the quantitative in vitro determination of HDL-cholesterol concentration in human serum and plasma. | HDL | RANDOX LABORATORIES LIMITED |
| 21 | 05055273201185 | CH2655 | 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. | DIRECT HDL-CHOLESTEROL (HDL) | RANDOX LABORATORIES LIMITED | |
| 22 | 04571226470831 | 14-531 | 14-531 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 23 | 04015630942589 | 07528604190 | 07528604190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
| 24 | 04015630942572 | 07528582190 | 07528582190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
| 25 | 04015630942565 | 07528566190 | 07528566190 | HDL-Cholesterol Gen.4 | ROCHE DIAGNOSTICS GMBH | |
| 26 | 04015630926879 | 05401488190 | 05401488190 | HDL-Cholesterol plus 3rd generation | ROCHE DIAGNOSTICS GMBH | |
| 27 | 00899722002344 | 99021 | 99021 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 28 | 00899722002337 | 99020 | 99020 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 29 | 00893038002654 | 10-991 | 10-991 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 30 | 00893038002647 | 10-990 | 10-990 | Alere Cholestech LDX® TC●HDL●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 31 | 00893038002630 | 10-989 | 10-989 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 32 | 00893038002616 | 10-987 | 10-987 | Alere Cholestech LDX® TC●HDL | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
| 33 | 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. |
| 34 | EABA40000251 | 400-0025 | 400-0025 | The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry an The Piccolo® Lipid Panel reagent disc, 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), and triglycerides (TRIG) 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 these 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.This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is 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 | ABAXIS, INC. |
| 35 | 00857969006594 | SA2038 | SA2038 | HDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
| 36 | 00857969006532 | SA1043 | SA1043 | HDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
| 37 | 00852169008164 | HDL1210 | HDL1210 | In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL | ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol | CLEARCHEM DIAGNOSTICS INC. |
| 38 | 00817302023060 | DT616 | DT616 | HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 39 | 00817302022216 | CC615 | CC615 | HDLD W/CALIBRATOR, 2 X 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 40 | 00817302022209 | AU-616 | AU-616 | HDLD (High Density Lipoprotein Direct) w/ cal 3 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 41 | 00817302022193 | BL616 | BL616 | HDLD (High Density Lipoprotein Direct) w/ cal 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 42 | 00817302022186 | ST616 | ST616 | HDLD (HDL Cholesterol Direct) w/ cal 2 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HDL RGT KIT Product No. ST616 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 43 | 00817274022856 | HDL4-250 | HDL4-250 | HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 44 | 00817274022252 | HDL4-125 | HDL4-125 | HDL CHOLESTEROL (2x 125mL R1, 2x 42mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 45 | 00817274021705 | XL-HDL4-40 | HDL, CHOLESTEROL (4x 40mL R1, 2x 45mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 46 | 00817274021699 | HDL4-BUL | HDL CHOLESTEROL Bulk | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 47 | 00817274021682 | HDL4-30 | HDL CHOLESTEROL (2x 30mL R1, 2x 10mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 48 | 00817274021675 | DG-HDL4-30 | HDL CHOLESTEROL (2 x 30mL R1, 2 x 10mL R2, 1 x 3mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 49 | 00812137012067 | R1 x 2 x 70mL, R2 x 1 x 50mL | 501-419 | The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determ The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. | HDL Cholesterol Reagent Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 50 | 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. | Sirrus® Direct HDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |