| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740194079 | 04Z2135 | 04Z2135 | Alinity i STAT High Sensitivity Troponin-I Reagent Kit 1200 test | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Alinity |
| 2 | 00380740169862 | 03P6834 | 03P6834 | CC MAGNESIUM 3750 Tests | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ARCHITECT |
| 3 | 00380740169855 | 03P6824 | 03P6824 | CC MAGNESIUM 1000 Tests | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ARCHITECT |
| 4 | 00380740164980 | 04V6201 | 04V6201 | Consolidated Chemistry Calibrator | JIX | Calibrator, multi-analyte mixture | 2 | Alinity |
| 5 | 00380740164973 | 04V1501 | 04V1501 | Consolidated Chemistry Calibrator | JIX | Calibrator, multi-analyte mixture | 2 | ARCHITECT |
| 6 | 00380740160623 | 07P5131 | 07P5131 | Alinity i Total B-hCG Reagent Kit 1200 Tests | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | 2 | Alinity |
| 7 | 00380740160616 | 07P5121 | 07P5121 | Alinity i Total B-hCG Reagent Kit | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | 2 | Alinity |
| 8 | 00380740158743 | 04U0930 | 04U0930 | Uric Acid2 2000 Tests | KNK | Acid, uric, uricase (colorimetric) | 1 | Alinity |
| 9 | 00380740158378 | 04U0920 | 04U0920 | Uric Acid2 640 Tests | KNK | Acid, uric, uricase (colorimetric) | 1 | Alinity |
| 10 | 00380740158361 | 04T1330 | 04T1330 | Uric Acid2 2000 Tests | CDO | Acid, uric, uricase (u.V.) | 1 | ARCHITECT |
| 11 | 00380740158354 | 04T1320 | 04T1320 | Uric Acid2 640 Tests | CDO | Acid, uric, uricase (u.V.) | 1 | ARCHITECT |
| 12 | 00380740158064 | 04T8630 | 04T8630 | Aspartate Aminotransferase2 3120 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | Alinity |
| 13 | 00380740158057 | 04T8620 | 04T8620 | Aspartate Aminotransferase2 1200 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | Alinity |
| 14 | 00380740155902 | 04T0030 | 04T0030 | Gamma-Glutamyl Transferase2 2600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ARCHITECT |
| 15 | 00380740155896 | 04T0020 | 04T0020 | Gamma-Glutamyl Transferase2 600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ARCHITECT |
| 16 | 00380740155759 | 04T9030 | 04S9030 | Aspartate Aminotransferase2 3960 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ARCHITECT |
| 17 | 00380740155742 | 04S8830 | 04S8830 | Alanine Aminotransferase2 3960 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ARCHITECT |
| 18 | 00380740155735 | 04T9020 | 04S9020 | Aspartate Aminotransferase2 1200 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ARCHITECT |
| 19 | 00380740155728 | 04S8820 | 04S8820 | Alanine Aminotransferase2 1200 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ARCHITECT |
| 20 | 00380740155711 | 04T8430 | 04T8430 | Alanine Aminotransferase2 3120 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | Alinity |
| 21 | 00380740155704 | 04T8420 | 04T8420 | Alanine Aminotransferase2 1200 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | Alinity |
| 22 | 00380740155476 | 04U4430 | 04U4430 | Total Protein2 3200 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ARCHITECT |
| 23 | 00380740155469 | 04U4420 | 04U4420 | Total Protein2 800 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ARCHITECT |
| 24 | 00380740155315 | 04T9630 | 04T9630 | Gamma-Glutamyl Transferase2 2100 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | Alinity |
| 25 | 00380740155308 | 04T9620 | 04T9620 | Gamma-Glutamyl Transferase2 600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | Alinity |
| 26 | 00380740155278 | 04T8130 | 04T8130 | Total Protein2 3120 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | Alinity |
| 27 | 00380740155261 | 04T8120 | 04T8120 | Total Protein2 800 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | Alinity |
| 28 | 00380740146221 | 08P4512 | 08P4512 | Alinity i 25-OH Vitamin D Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
| 29 | 00380740144883 | 07K6437 | 07K6437 | ARCHITECT Total T3 Reagent Kit (500T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 30 | 00380740144876 | 07K6432 | 07K6432 | ARCHITECT Total T3 Reagent Kit (2000T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 31 | 00380740144869 | 07K6427 | 07K6427 | ARCHITECT Total T3 Reagent Kit (100T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 32 | 00380740144845 | 07K6402 | 07K6402 | ARCHITECT Total T3 Calibrators | JIT | Calibrator, secondary | 2 | ARCHITECT |
| 33 | 00380740144838 | 07K6337 | 07K6337 | ARCHITECT Free T3 Reagent Kit (500T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 34 | 00380740144821 | 07K6332 | 07K6332 | ARCHITECT Free T3 Reagent Kit (2000T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 35 | 00380740144814 | 07K6327 | 07K6327 | ARCHITECT Free T3 Reagent Kit (100T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 36 | 00380740144807 | 07K6312 | 07K6312 | ARCHITECT Free T3 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | ARCHITECT |
| 37 | 00380740144791 | 07K6302 | 07K6302 | ARCHITECT Free T3 Calibrators | JIT | Calibrator, secondary | 2 | ARCHITECT |
| 38 | 00380740142759 | 5P02-12 | 05P0212 | ARCHITECT 25-OH Vitamin D Controls | MRG,JJX,JIT | SYSTEM, TEST, VITAMIN D,Single (specified) analyte controls (assayed and unassay SYSTEM, TEST, VITAMIN D,Single (specified) analyte controls (assayed and unassayed),CALIBRATOR, SECONDARY | 1 | ARCHITECT |
| 39 | 00380740142742 | 5P02-02 | 05P0202 | ARCHITECT 25-OH Vitamin D Calibrators | JIT,JJX,MRG | CALIBRATOR, SECONDARY,Single (specified) analyte controls (assayed and unassayed CALIBRATOR, SECONDARY,Single (specified) analyte controls (assayed and unassayed),SYSTEM, TEST, VITAMIN D | 1 | ARCHITECT |
| 40 | 00380740136710 | 08P3640 | 08P3640 | Alinity i Progesterone Manual Diluent | JLS | RADIOIMMUNOASSAY, PROGESTERONE | 1 | Alinity |
| 41 | 00380740136703 | 07P6731 | 07P6731 | Alinity i B12 Reagent Kit 1200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
| 42 | 00380740136697 | 07P6721 | 07P6721 | Alinity i B12 Reagent Kit 200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
| 43 | 00380740136680 | 07P6712 | 07P6712 | Alinity i B12 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
| 44 | 00380740136673 | 07P6702 | 07P6702 | Alinity i B12 Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
| 45 | 00380740136567 | 08P1431 | 08P1431 | Alinity i Folate Reagent Kit 1200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
| 46 | 00380740136550 | 08P1421 | 08P1421 | Alinity i Folate Reagent Kit 200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
| 47 | 00380740136543 | 08P1412 | 08P1412 | Alinity i Folate Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
| 48 | 00380740136536 | 08P1402 | 08P1402 | Alinity i Folate Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
| 49 | 00380740131647 | 07P4930 | 07P4930 | Alinity i FSH Reagent Kit 1200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
| 50 | 00380740131630 | 07P4920 | 07P4920 | Alinity i FSH Reagent Kit 200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 2 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 3 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 4 | 05391516741866 | 450-11 | 450-11 | Bile Acid Calibrator Set (5 x 5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 5 | 05391516741859 | 450-100 | 450-100 | Bile Acid Calibrator 100 umol/l (5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 6 | 05055845400282 | FHBC100/B08176 | FHBC100/B08176 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 7 | 05055845400169 | FHRWR100 | FHRWR100 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 8 | 05055273216882 | CYS10445 | CYS10445 | Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. | CYSTATIN C CALIBRATOR (CYSC CAL) | RANDOX LABORATORIES LIMITED |
| 9 | 05055273215557 | TF10161 | TF10161 | The Randox Soluble Transferrin Receptors Calibrator Series is intended for use i The Randox Soluble Transferrin Receptors Calibrator Series is intended for use in the calibration of Soluble Transferrin Receptors assays. | SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) | RANDOX LABORATORIES LIMITED |
| 10 | 05055273215540 | HA8124 | HA8124 | The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay. | HbA1c II CALIBRATOR SET (HbA1c II CAL) | RANDOX LABORATORIES LIMITED |
| 11 | 05055273214550 | SC10154 | SC10154 | This product is intended for in vitro diagnostic use, in the calibration of the This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. | RANSEL CALIBRATOR (RANSEL CAL) | RANDOX LABORATORIES LIMITED |
| 12 | 05055273213904 | AO2800 | ADIPONECTIN CALIBRATOR (ADPN CAL) | RANDOX LABORATORIES LIMITED | ||
| 13 | 05055273209204 | LP5047 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | RANDOX LABORATORIES LIMITED | ||
| 14 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
| 15 | 05055273208436 | CH5050 | sLDL CALIBRATOR (sLDL CAL) | RANDOX LABORATORIES LIMITED | ||
| 16 | 05055273208405 | CG5037 | COAGULATION CALIBRATOR (COAG CAL) | RANDOX LABORATORIES LIMITED | ||
| 17 | 05055273207842 | DA2700 | DA2700 | The Randox Cannabinoid Calibrator Set is intended for use in the calibration of The Randox Cannabinoid Calibrator Set is intended for use in the calibration of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. | THC CAL | RANDOX LABORATORIES LIMITED |
| 18 | 05055273207439 | CYS2699 | CYS2699 | The device is intended to be used for in the calibration of Cystatin C assays. | CYSC CAL | RANDOX LABORATORIES LIMITED |
| 19 | 05055273204520 | MA1567 | MICROALBUMIN CALIBRATOR SERIES (mALB CAL) | RANDOX LABORATORIES LIMITED | ||
| 20 | 05055273204285 | LO2306 | ANTI-STREPTOLYSIN O STANDARD (ASO STD) | RANDOX LABORATORIES LIMITED | ||
| 21 | 05055273204056 | IT3861 | IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL) | RANDOX LABORATORIES LIMITED | ||
| 22 | 05055273203424 | GR2609 | GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) | RANDOX LABORATORIES LIMITED | ||
| 23 | 05055273203110 | FR2993 | FR2993 | This product is intended for in vitro diagnostic use in the calibration of the R This product is intended for in vitro diagnostic use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. | FRUC CAL | RANDOX LABORATORIES LIMITED |
| 24 | 05055273201451 | CK2393 | CK2393 | The device is intended for use in the calibration of CK-MB assays in clinical ch The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems. | CK-MB CAL | RANDOX LABORATORIES LIMITED |
| 25 | 05055273200768 | BM1362 | BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) | RANDOX LABORATORIES LIMITED | ||
| 26 | 05055273200089 | AD5000 | AD5000 | The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the c The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189. | ALS CAL | RANDOX LABORATORIES LIMITED |
| 27 | 05051700016698 | NK012.10S | Human IgM kit for use on SPAPLUS- Bulk Kit | THE BINDING SITE GROUP LIMITED | ||
| 28 | 05051700012249 | NK012.S | Human IgM kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
| 29 | 04987486015147 | 103400 | The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used fo The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin. | Calibrator 80 | ARKRAY USA, INC. | |
| 30 | 04987481164475 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | uTASWako DCP Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
| 31 | 04987481164437 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
| 32 | 04987270234181 | 234181 | Lumipulse G HE4 Calibrators | FUJIREBIO INC. | ||
| 33 | 04987270234150 | 234150 | Lumipulse G BRAHMS PCT Calibrator Set | FUJIREBIO INC. | ||
| 34 | 04987270234020 | 234020 | Lumipulse G 25-OH Vitamin D Calibrators | FUJIREBIO INC. | ||
| 35 | 04987270233849 | 233849 | Lumipulse G E2-III Calibrators | FUJIREBIO INC. | ||
| 36 | 04987270231135 | 231135 | Lumipulse G TSH-III Calibrators | FUJIREBIO INC. | ||
| 37 | 04987270230954 | 230954 | Lumipulse G Prolactin Calibrators | FUJIREBIO INC. | ||
| 38 | 04987270230930 | 230930 | Lumipulse G FSH-N Calibrators | FUJIREBIO INC. | ||
| 39 | 04987270230916 | 230916 | Lumipulse G LH Calibrators | FUJIREBIO INC. | ||
| 40 | 04987270230893 | 230893 | Lumipulse G Progesterone-N Calibrators | FUJIREBIO INC. | ||
| 41 | 04987270230688 | 230688 | Lumipulse G CA125II Calibrators | FUJIREBIO INC. | ||
| 42 | 04987153301054 | G252GA | G252GA | Calibrator L (1 mL × 1), Calibrator H (1 mL × 1) | Calibrator for Lucica® Glycated Albumin-L | ASAHI KASEI PHARMA CORPORATION |
| 43 | 04560189213456 | N/A | ST AIA-PACK PROG III CALIBRATOR SET | TOSOH CORPORATION | ||
| 44 | 04560189213395 | N/A | ST AIA-PACK PROG II CALIBRATOR SET | TOSOH CORPORATION | ||
| 45 | 04560189213364 | N/A | ST AIA-PACK SHBG CALIBRATOR SET | TOSOH CORPORATION | ||
| 46 | 04560189213333 | N/A | AIA-PACK C-Peptide II Calibrator Set | TOSOH CORPORATION | ||
| 47 | 04560189213135 | N/A | ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET | TOSOH CORPORATION | ||
| 48 | 04560189212886 | N/A | 0025328 | ST AIA-PACK BNP CALIBRATOR SET | TOSOH CORPORATION | |
| 49 | 04560189212787 | N/A | ST AIA-PACK Homocysteine Calibrator Set | TOSOH CORPORATION | ||
| 50 | 04560189212749 | N/A | ST AIA-PACK hsE2 CALIBRATOR SET | TOSOH CORPORATION |