| 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 | 00852169008164 | HDL1210 | HDL1210 | In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL | LBS | LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL | 1 | ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol |
| 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 | 10304040080594 | 5701036 | 5701036 | Handheld portable analyzer for Lipid and Glucose Testing, Blood Sample used is 40ul | Henry Schein | HENRY SCHEIN, INC. |
| 2 | 07613336157824 | 08445699190 | 08445699190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
| 3 | 07613336140680 | 08105677190 | 08105677190 | Fructosamine | ROCHE DIAGNOSTICS GMBH | |
| 4 | 07613336120927 | 08056668190 | 08056668190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
| 5 | 07070060005683 | 1115015 | 1115015 | Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in hu Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c. | Alere Afinion™ HbA1c | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| 6 | 05391516749473 | Tri-stat 2 Analyzer | 03-06-0002 | Tri-stat 2 Analyzer | Trinity Biotech | PRIMUS CORPORATION |
| 7 | 05391516748636 | PDQ Wash Reagent | 01-03-0067 | Hemoglobin A1c assay, PDQ Wash Reagent | Trinity Biotech | PRIMUS CORPORATION |
| 8 | 05391516748629 | PDQ Diluent Reagent - 940mL | 01-03-0066 | Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 9 | 05391516748612 | PDQ 2 Reagent - 940mL | 01-03-0065 | Hemoglobin A1c assay, PDQ 2 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 10 | 05391516748605 | PDQ1 Reagent - 940mL | 01-03-0064 | Hemoglobin A1c assay, PDQ1 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 11 | 05391516748223 | Tri-stat Reagent Kit | 03-06-0010 | Hemoglobin A1c assay, Tri-stat Reagent Kit | Trinity Biotech | PRIMUS CORPORATION |
| 12 | 05391516748162 | Ultra2 Affinity A1c 3000 | 01-04-0080 | Hemoglobin A1c assay, Ultra2 Affinity A1c 3000 | Trinity Biotech | PRIMUS CORPORATION |
| 13 | 05391516748155 | Ultra2 Affinity HbA1c Analyzer (110V) | 03-01-0052 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V) | Trinity Biotech | PRIMUS CORPORATION |
| 14 | 05391516748148 | Premier Affinity A1c 3000 - 1 kit | 09-03-0007 | Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
| 15 | 05391516748131 | Premier Affinity A1c 1000 - 1 kit | 09-03-0010 | Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
| 16 | 05391516748124 | Premier Affinity A1c 500 - 1 kit | 09-03-0008 | Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
| 17 | 05391516748117 | Premier Sample Diluent Reagent - 940mL | 01-03-0101 | Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 18 | 05391516748100 | Premier Buffer B Reagent - 3.8L | 01-03-0081 | Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
| 19 | 05391516748094 | Premier Buffer A Reagent - 3.8L | 01-03-0080 | Hemoglobin A1c assay, Premier Buffer A Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
| 20 | 05391516748063 | Premier Hb9210 HbA1c Analytical Column (500) | 09-06-0050 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500) | Trinity Biotech | PRIMUS CORPORATION |
| 21 | 05391516748056 | Premier Hb9210 HbA1c Analytical Column (1000) | 09-06-0046 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (1000) | Trinity Biotech | PRIMUS CORPORATION |
| 22 | 05391516744799 | Premier Wash Reagent - 940mL | 01-03-0098 | Hemoglobin A1c assay, Premier Wash Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 23 | 05391516744782 | Premier Diluent Reagent - 3.8L | 01-03-0097 | Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
| 24 | 05391516744775 | Premier Buffer B Reagent - 940mL | 01-03-0096 | Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 25 | 05391516744768 | Premier Buffer A Reagent - 940mL | 01-03-0095 | Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 26 | 05391516744751 | Premier Hb9210 HbA1c Analyzer - 1 each | 09-00-0001 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer | Trinity Biotech | PRIMUS CORPORATION |
| 27 | 05391516744553 | Affinity Analytical Column | 03-02-0079 | Hemoglobin A1c assay, Affinity Analytical Column | Trinity Biotech | PRIMUS CORPORATION |
| 28 | 05391516744546 | Enzyme Cleaner Tube | 01-12-0001 | Hemoglobin A1c assay, Enzyme Cleaner Tube | Trinity Biotech | PRIMUS CORPORATION |
| 29 | 05391516744317 | 2 Diluent Reagent - 940mL | 01-03-0059 | Hemoglobin A1c assay, 2 Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 30 | 05391516744294 | 2 Diluent Reagent - 3.8L | 01-03-0058 | Hemoglobin A1c assay, 2 Diluent Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
| 31 | 05391516744287 | Ultra2 Buffer 2A Reagent - 3.8L | 01-03-0054 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
| 32 | 05391516744270 | Ultra2 Buffer 2A Reagent - 940mL | 01-03-0053 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 33 | 05391516744218 | System Wash Reagent - 940mL | 01-03-0035 | Hemoglobin A1c assay, System Wash Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 34 | 05391516744171 | Ultra2 Buffer B Reagent - 3.8L | 01-03-0012 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L | Trinity Biotech | PRIMUS CORPORATION |
| 35 | 05391516744164 | Ultra2 Buffer B Reagent - 940mL | 01-03-0011 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
| 36 | 05391516744126 | Ultra2 Affinity HbA1c Analyzer (220V) | 03-01-0048 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (220V) | Trinity Biotech | PRIMUS CORPORATION |
| 37 | 05055273208856 | HA8321 | HA8321 | The product is intended for the quantitative in vitro determination of Haemoglob The product is intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood. | HbA1C | RANDOX LABORATORIES LIMITED |
| 38 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
| 39 | 05055273208726 | FR3133 | FR3133 | Enzymatic assay for the quantitative in vitro determination of glycated protein Enzymatic assay for the quantitative in vitro determination of glycated protein (fructosamine) in human serum or plasma. | FRUC | RANDOX LABORATORIES LIMITED |
| 40 | 05055273203561 | HA3830 | HA3830 | A Haemoglobin A1c test system is a device intended for the quantitative in vitro A Haemoglobin A1c test system is a device intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood | HbA1C | RANDOX LABORATORIES LIMITED |
| 41 | 05055273203554 | HA3450 | HA3450 | HAEMOGLOBIN A1c (HbA1c) | RANDOX LABORATORIES LIMITED | |
| 42 | 05055273203530 | HA3444 | HA3444 | This product is intended for in vitro diagnostic use in the calibration of HbA1c This product is intended for in vitro diagnostic use in the calibration of HbA1c on clinical chemistry systems. | HbA1C CAL | RANDOX LABORATORIES LIMITED |
| 43 | 04987153301047 | L242GA | L242GA | ALB R-2 Coloring solution 20mL x 2 | Lucica® Glycated Albumin-L ALB R-2 | ASAHI KASEI PHARMA CORPORATION |
| 44 | 04987153301030 | L232GA | L232GA | ALB R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L ALB R-1 | ASAHI KASEI PHARMA CORPORATION |
| 45 | 04987153301023 | L222GA | L222GA | GA R-2 Enzymatic solution 10mL x 2 | Lucica® Glycated Albumin-L GA R-2 | ASAHI KASEI PHARMA CORPORATION |
| 46 | 04987153301016 | L212GA | L212GA | GA R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L GA R-1 | ASAHI KASEI PHARMA CORPORATION |
| 47 | 04560189283640 | N/A | Hemoglobin A1c Calibrator Set | TOSOH CORPORATION | ||
| 48 | 04560189283626 | N/A | G8 Variant Elution Buffer HSi No.3 (S) | TOSOH CORPORATION | ||
| 49 | 04560189283619 | N/A | G8 Variant Elution Buffer HSi No.2 (S) | TOSOH CORPORATION | ||
| 50 | 04560189283602 | N/A | G8 Variant Elution Buffer HSi No.1 (S) | TOSOH CORPORATION |