No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
26 | 00380740185787 | 09P261B | 09P261B | Alinity i Active B12 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
27 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
28 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
29 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
30 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
31 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
32 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
33 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
34 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
35 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
36 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
37 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
38 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
39 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
40 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
41 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
42 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
43 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
44 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
45 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
46 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
47 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
48 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
49 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
50 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 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 |
3 | 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 |
4 | 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 |
5 | 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 |
6 | 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 |
7 | 05055273213904 | AO2800 | ADIPONECTIN CALIBRATOR (ADPN CAL) | RANDOX LABORATORIES LIMITED | ||
8 | 05055273209204 | LP5047 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | RANDOX LABORATORIES LIMITED | ||
9 | 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 |
10 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
11 | 05055273208733 | FR4030 | FR4030 | FRUCTOSAMINE (FRUC) | RANDOX LABORATORIES LIMITED | |
12 | 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 |
13 | 05055273208436 | CH5050 | sLDL CALIBRATOR (sLDL CAL) | RANDOX LABORATORIES LIMITED | ||
14 | 05055273208405 | CG5037 | COAGULATION CALIBRATOR (COAG CAL) | RANDOX LABORATORIES LIMITED | ||
15 | 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 |
16 | 05055273207439 | CYS2699 | CYS2699 | The device is intended to be used for in the calibration of Cystatin C assays. | CYSC CAL | RANDOX LABORATORIES LIMITED |
17 | 05055273204520 | MA1567 | MICROALBUMIN CALIBRATOR SERIES (mALB CAL) | RANDOX LABORATORIES LIMITED | ||
18 | 05055273204285 | LO2306 | ANTI-STREPTOLYSIN O STANDARD (ASO STD) | RANDOX LABORATORIES LIMITED | ||
19 | 05055273204056 | IT3861 | IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL) | RANDOX LABORATORIES LIMITED | ||
20 | 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 |
21 | 05055273203554 | HA3450 | HA3450 | HAEMOGLOBIN A1c (HbA1c) | RANDOX LABORATORIES LIMITED | |
22 | 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 |
23 | 05055273203424 | GR2609 | GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) | RANDOX LABORATORIES LIMITED | ||
24 | 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 |
25 | 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 |
26 | 05055273200768 | BM1362 | BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) | RANDOX LABORATORIES LIMITED | ||
27 | 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 |
28 | 05051700016698 | NK012.10S | Human IgM kit for use on SPAPLUS- Bulk Kit | THE BINDING SITE GROUP LIMITED | ||
29 | 05051700012249 | NK012.S | Human IgM kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
30 | 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. | |
31 | 04987481164475 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | uTASWako DCP Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
32 | 04987481164437 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
33 | 04987270234181 | 234181 | Lumipulse G HE4 Calibrators | FUJIREBIO INC. | ||
34 | 04987270234150 | 234150 | Lumipulse G BRAHMS PCT Calibrator Set | FUJIREBIO INC. | ||
35 | 04987270234020 | 234020 | Lumipulse G 25-OH Vitamin D Calibrators | FUJIREBIO INC. | ||
36 | 04987270233849 | 233849 | Lumipulse G E2-III Calibrators | FUJIREBIO INC. | ||
37 | 04987270231135 | 231135 | Lumipulse G TSH-III Calibrators | FUJIREBIO INC. | ||
38 | 04987270230954 | 230954 | Lumipulse G Prolactin Calibrators | FUJIREBIO INC. | ||
39 | 04987270230930 | 230930 | Lumipulse G FSH-N Calibrators | FUJIREBIO INC. | ||
40 | 04987270230916 | 230916 | Lumipulse G LH Calibrators | FUJIREBIO INC. | ||
41 | 04987270230893 | 230893 | Lumipulse G Progesterone-N Calibrators | FUJIREBIO INC. | ||
42 | 04987270230688 | 230688 | Lumipulse G CA125II Calibrators | FUJIREBIO INC. | ||
43 | 04987153301054 | G252GA | G252GA | Calibrator L (1 mL × 1), Calibrator H (1 mL × 1) | Calibrator for Lucica® Glycated Albumin-L | ASAHI KASEI PHARMA CORPORATION |
44 | 04987153301047 | L242GA | L242GA | ALB R-2 Coloring solution 20mL x 2 | Lucica® Glycated Albumin-L ALB R-2 | ASAHI KASEI PHARMA CORPORATION |
45 | 04987153301030 | L232GA | L232GA | ALB R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L ALB R-1 | ASAHI KASEI PHARMA CORPORATION |
46 | 04987153301023 | L222GA | L222GA | GA R-2 Enzymatic solution 10mL x 2 | Lucica® Glycated Albumin-L GA R-2 | ASAHI KASEI PHARMA CORPORATION |
47 | 04987153301016 | L212GA | L212GA | GA R-1 Pretreatment solution 40 mL x 2 | Lucica® Glycated Albumin-L GA R-1 | ASAHI KASEI PHARMA CORPORATION |
48 | 04560189283640 | N/A | Hemoglobin A1c Calibrator Set | TOSOH CORPORATION | ||
49 | 04560189283626 | N/A | G8 Variant Elution Buffer HSi No.3 (S) | TOSOH CORPORATION | ||
50 | 04560189283619 | N/A | G8 Variant Elution Buffer HSi No.2 (S) | TOSOH CORPORATION |