| 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 | 06438115000112 | 145217 | 145217 | QuikRead go® CRP Control Set is intended for use as assayed quality-control mate QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument. | QuikRead go® CRP Control set | AIDIAN OY |
| 2 | 06438115000105 | 145216 | 145216 | QuikRead go® CRP Verification Set is designed to be used for calibration verific QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. | QuikRead go® CRP Verification set | AIDIAN OY |
| 3 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 4 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 5 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 6 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 7 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 8 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 9 | 05415168004763 | 08240426190 | 08240426190 | Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems. | Alpha2-Macroglobulin Serum CONT KIT | DIAGAM |
| 10 | 05391516748216 | Tri-stat Liquid Controls Kit | 03-06-0011 | Hemoglobin A1c assay, Tri-stat Liquid Controls Kit | Trinity Biotech | PRIMUS CORPORATION |
| 11 | 05391516747240 | A7040 | A7040 | ACE CONTROL-E | Trinity Biotech | CLARK LABORATORIES, INC. |
| 12 | 05391516747233 | A6040 | A6040 | ACE CONTROL-N | Trinity Biotech | CLARK LABORATORIES, INC. |
| 13 | 05391516741897 | 450-22 | 450-22 | Bile Acids Controls | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 14 | 05391516741866 | 450-11 | 450-11 | Bile Acid Calibrator Set (5 x 5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 15 | 05391516741859 | 450-100 | 450-100 | Bile Acid Calibrator 100 umol/l (5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 16 | 05060169695979 | IS-ID6530 | IDS SARS-COV-2 IgG Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 17 | 05060169695825 | IS-2835US | IDS-iSYS Ostase® BAP Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 18 | 05060169695818 | IS-2830US | IDS-iSYS Ostase® BAP Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 19 | 05060169695504 | IS-4620 | IDS Cortisol Calibrator Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 20 | 05060169695306 | IS-2530 | IDS-iSYS 25 VitDS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 21 | 05060169693708 | IS-5635 | IDS SHBG Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 22 | 05060169691339 | IS-5630 | IDS SHBG Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 23 | 05060169691070 | IS-5135 | IDS-iSYS 17-OH Progesterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 24 | 05060169691049 | IS-4835 | IDS-iSYS Direct Renin Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 25 | 05060169691001 | IS-4435 | IDS-iSYS Insulin like Growth Factor Binding Protein-3 (IGFBP-3) Cal Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 26 | 05060169690981 | IS-3935 | IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 27 | 05060169690974 | IS-3735 | IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 28 | 05060169690967 | IS-3335 | IDS-iSYS Aldosterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 29 | 05060169690950 | IS-3235 | IDS-iSYS Intact PTH Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 30 | 05060169690943 | IS-3035 | IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 31 | 05060169690929 | IS-2535 | IDS-iSYS 25 VitDS Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 32 | 05060169690912 | IS-2435 | IDS-iSYS 1,25-Dihydroxy Vitamin D Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 33 | 05060169690882 | IS-5130 | IDS-iSYS 17-OH Progesterone Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 34 | 05060169690851 | IS-4830 | IDS-iSYS Direct Renin Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 35 | 05060169690820 | IS-4630 | IDS Cortisol Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 36 | 05060169690752 | IS-2530 | IDS-iSYS 25 VitDS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 37 | 05060169690424 | IS-2735S | IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 38 | 05060169690417 | IS-2730S | IDS-iSYS 25-Hydroxy Vitamin DS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 39 | 05060169690370 | IS-3330 | IDS-iSYS Aldosterone Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 40 | 05060169690356 | IS-2430 | IDS-iSYS 1,25-Dihydroxy Vitamin D Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 41 | 05060169690318 | IS-4430 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 42 | 05060169690295 | IS-3930 | IDS-iSYS Insulin like Growth Factor-1 (IGF-I) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 43 | 05060169690271 | IS-3230 | IDS-iSYS Intact PTH Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 44 | 05060169690257 | IS-3030 | IDS-iSYS CTX-I (Crosslaps) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 45 | 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 |
| 46 | 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 |
| 47 | 05055845400022 | FHCY200 | FHCY200 | The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed qu The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. | Axis-Shield Homocysteine Controls | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 48 | 05055845400015 | FHCY100 | FHCY100 | The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis® Homocysteine EIA | AXIS-SHIELD DIAGNOSTICS LIMITED |
| 49 | 05055273217797 | AMH10515 | AMH10515 | The AMH Control Level 3 (AMH10515) is intended for use with in vitro diagnostic The AMH Control Level 3 (AMH10515) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 3 (AMH10515) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 3 (AMH10515) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | AMH CONTROL LEVEL 3 (AMH CONTROL 3) | RANDOX LABORATORIES LIMITED |
| 50 | 05055273217780 | AMH10514 | AMH10514 | The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 2 (AMH10514) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | AMH CONTROL LEVEL 2 (AMH CONTROL 2) | RANDOX LABORATORIES LIMITED |