| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04250317548498 | 0274 | 0274 | MassCheck® Vitamins B1 and B6, Whole Blood Control Level II | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Whole Blood Control |
| 2 | 04250317547941 | 0273 | 0273 | MassCheck® Vitamins B1 and B6, Whole Blood Control Level I | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Whole Blood Control |
| 3 | 04250317546494 | 0315 | 0315 | MassCheck® Methylmalonic Acid Plasma Control Level II | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pasma Control |
| 4 | 04250317544100 | 0078 | 0078 | Whole blood control Level I, Glutathione in whole blood | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Whole Blood Control |
| 5 | 04250317544087 | 0089 | 0089 | MassCheck® Immunosuppressants Whole Blood Blank Control | LAS | Drug Specific Control Materials | 1 | Whole Blood Control |
| 6 | 04250317543974 | 0085 | 0085 | MassCheck® Immunosuppressants Whole Blood Control Level VI | LAS | Drug Specific Control Materials | 1 | Whole Blood Control |
| 7 | 04250317543967 | 0084 | 0084 | MassCheck® Immunosuppressants Whole Blood Control Level III | LAS | Drug Specific Control Materials | 1 | Whole Blood Control |
| 8 | 04250317543950 | 0083 | 0083 | MassCheck® Immunosuppressants Whole Blood Control Level II | LAS | Drug Specific Control Materials | 1 | Whole Blood Control |
| 9 | 04250317543943 | 0082 | 0082 | MassCheck® Immunosuppressants Whole Blood Control Level I | LAS | Drug Specific Control Materials | 1 | Whole Blood Control |
| 10 | 04250317543868 | 0060 | 0060 | Serum Control Level I, Antiepileptic Drugs in serum/plasma | LAS | Drug Specific Control Materials | 1 | Serum Control |
| 11 | 04250317543578 | 0035 | 0035 | Whole Blood Control Level II, Vitamins B1/B2 in whole blood | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Whole Blood Control |
| 12 | 04250317543554 | 0034 | 0034 | Whole Blood Control Level I, Vitamins B1/B2 in whole blood | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Whole Blood Control |
| 13 | 04250317543400 | 0023 | 0023 | Whole Blood Control Level I, Vitamin B6 in whole blood | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Whole Blood Control |
| 14 | 04250317543226 | 1003/B | 1003/B | Calibration Standard VMA, HVA, 5-HIAA | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibration Standard |
| 15 | 04250317526038 | 0316 | 0316 | MassCheck® Methylmalonic Acid Urine Control Bi-Level | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Urine Control Bi-Level |
| 16 | 04250317523167 | 0081 | 0081 | MassCheck® Immunosuppressants Whole Blood Control Four-Level | LAS | Drug Specific Control Materials | 1 | Whole Blood Control Four Level |
| 17 | 04250317513281 | 6003 | 6003 | Calibration Standard Catecholamines | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibration Standard |
| 18 | 04250317511119 | 5003 | 5003 | Calibration Standard Catecholamines | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibration Standard |
| 19 | 04250317508874 | 0045 | 0045 | Urine Control Bi-Level Crosslinks in urine | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Urine Control Bi-Level |
| 20 | 04250317505378 | 3033 | 3033 | Calibration Standard Serotonin | JIT | Calibrator, Secondary | 2 | Calibration Standard |
| 21 | 04250317505217 | 3003 | 3003 | Calibration Standard Serotonin | JIT | Calibrator, Secondary | 2 | Calibration Standard |
| 22 | 04250317503114 | 2023 | 2023 | Calibration Standard Metanephrines | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibration Standard |
| 23 | 04250317502148 | 0161 | 0161 | Urine Control Bi-Level, t,t-Muconic acid in urine | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | Urine Control Bi-Level |
| 24 | 04250317501271 | 0144 | 0144 | Urine Control Bi-Level, Porphyrins in urine | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | Urine Control Bi-Level |
| 25 | 04250317501226 | 0141 | 0141 | Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic A Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | Urine Control Bi-Level |
| 26 | 04250317501127 | 0138 | 0138 | Urine Control Bi-Level, o-Cresol, p-Cresol, Phenol in urine | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | Urine Control Bi-Level |
| 27 | 04250317551115 | 75228 | 75228 | 3PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibrator Set |
| 28 | 04250317550705 | 34966 | 34966 | Pre-mixed Solution | JOA | Acid, Trifluoroacetic, Vitamin A, Hexane Extraction | 1 | Reagent |
| 29 | 04250317547460 | 65765/F | 65765/F | HPLC Reagent Kit for automated sample preparation, Vitamin C in plasma/serum | JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | 1 | Reagent Kit |
| 30 | 04250317546463 | 81004 | 81004 | Internal Standard Mix, MassChrom® Free Metanephrines in plasma | CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | Reagent |
| 31 | 04250317546449 | 80604/5 | 80604/5 | Internal Standard Mix, MassChrom® Catecholamines, free Metanephrines, Serotonin in urine | CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | Reagent |
| 32 | 04250317546333 | 4009 | 4009 | Urine Calibration Standard Serotonin | JIT | Calibrator, Secondary | 2 | Urine Calibration Standard |
| 33 | 04250317546234 | 80804/5 | 80804/5 | Internal Standard Mix, MassChrom® VMA, HVA, 5-HIAA in urine | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | Reagent |
| 34 | 04250317545237 | 41003 | 41003 | Urine Calibration Standard o-Cresol, p-Cresol, Phenol | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 35 | 04250317545077 | 47003 | 47003 | Urine Calibration Standard t,t-Muconic Acid | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 36 | 04250317544797 | 53003 | 53003 | Urine Calibration Standard 1-Hydroxypyrene | JIT | Calibrator, Secondary | 2 | Urine Calibration Standard |
| 37 | 04250317508768 | 44002 | 44002 | Mobile Phase B, Porphyrins in urine | JKJ | Fluorometric Measurement, Porphyrins | 1 | Reagent |
| 38 | 04250317543875 | 6009 | 6009 | Urine Calibration Standard Catecholamines | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 39 | 04250317543738 | 48003 | 48003 | Urine Calibration Standard Crosslinks | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 40 | 04250317543370 | 2009 | 2009 | Urine Calibration Standard Metanephrines | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 41 | 04250317543240 | 1099 | 1099 | Potential Optimisation Mix, VMA, HVA, 5-HIAA in urine | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | Reagent |
| 42 | 04250317543233 | 1009 | 1009 | Urine Calibration Standard VMA, HVA, 5-HIAA | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 43 | 04250317542854 | 44003 | 44003 | Urine Calibration Standard Porphyrins | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 44 | 04250317542755 | 43003 | 43003 | Urine Calibration Standard Occupational Medicine | JIX | Calibrator, Multi-Analyte Mixture | 2 | Urine Calibration Standard |
| 45 | 04250317542397 | 96033 | 96033 | Urine Screening Standard Set MassTox® Drugs of Abuse Testing in urine | DLJ | Calibrators, Drug Specific | 2 | Urine Calibrator Set |
| 46 | 04250317542342 | 96040 | 96040 | 6PLUS1® Multilevel Urine Calibrator Set MassTox® Drugs of Abuse Testing in urine | DLJ | Calibrators, Drug Specific | 2 | Urine Calibrator Set |
| 47 | 04250317540065 | 81000/C | 81000/C | LC-MS/MS Reagent Kit, including Sample Clean Up Columns, MassChrom® Free Metanep LC-MS/MS Reagent Kit, including Sample Clean Up Columns, MassChrom® Free Metanephrines in plasma | CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | Reagent Kit |
| 48 | 04250317540058 | 81002 | 81002 | Mobile Phase B, MassChrom® Free Metanephrines in plasma | CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | Reagent |
| 49 | 04250317540041 | 81001 | 81001 | Mobile Phase A, MassChrom® Free Metanephrines in plasma | CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | Reagent |
| 50 | 04250317539953 | 81015 | 81015 | Tuning Mix, MassChrom® Free Metanephrines in plasma | CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | Reagent |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 17350066140579 | 660-20 | AMH Control | FUJIREBIO DIAGNOSTICS AB | ||
| 2 | 17350066140531 | 240-20 | Lung Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
| 3 | 17350066140524 | 360-20 | Mesothelin Control | FUJIREBIO DIAGNOSTICS AB | ||
| 4 | 17350066140043 | 108-20 | Tumor Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
| 5 | 17290018739072 | FG00004 | The Performance Verification Kit contains a set of serum-based quantitative samp The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only. | Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP | MEMED DIAGNOSTICS LTD | |
| 6 | 15099590233877 | 657365 | 657365 | SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum | Synchron | BECKMAN COULTER, INC. |
| 7 | 15099590228743 | 465939 | 465939 | SYNCHRON Systems 125 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
| 8 | 15099590227357 | 450163 | 450163 | Vigil Serology Control Level 2 | Vigil | BECKMAN COULTER, INC. |
| 9 | 15099590227333 | 450164 | 450164 | Vigil Serology Control Level 3 | Vigil | BECKMAN COULTER, INC. |
| 10 | 15099590227326 | 465440 | 465440 | Vigil Serology Control Level C | Vigil | BECKMAN COULTER, INC. |
| 11 | 15099590227258 | 465912 | 465912 | SYNCHRON Systems 75 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
| 12 | 15099590227234 | 465914 | 465914 | SYNCHRON Systems 20 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
| 13 | 15099590226916 | 450120 | 450120 | Vigil Protein Control Level 1 | Vigil | BECKMAN COULTER, INC. |
| 14 | 15099590225384 | 465290 | 465290 | Immunochemistry Systems Level 1 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
| 15 | 15099590224158 | 465300 | 465300 | Immunochemistry Systems Level 2 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
| 16 | 15099590223045 | 450125 | 450125 | Vigil Protein Control Level 2 | Vigil | BECKMAN COULTER, INC. |
| 17 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | Vigil | BECKMAN COULTER, INC. |
| 18 | 15099590222918 | 465981 | 465981 | Vigil Lipid Control Level 3 | Vigil | BECKMAN COULTER, INC. |
| 19 | 15099590222901 | 465982 | 465982 | Vigil Lipid Control Level 4 | Vigil | BECKMAN COULTER, INC. |
| 20 | 15099590222611 | 450130 | 450130 | Vigil Protein Control Level 3 | Vigil | BECKMAN COULTER, INC. |
| 21 | 15099590222604 | 450162 | 450162 | Vigil Serology Control Level 1 | Vigil | BECKMAN COULTER, INC. |
| 22 | 15099590222000 | 474988 | 474988 | SYNCHRON Systems OP 300 Low Urine Control | Synchron | BECKMAN COULTER, INC. |
| 23 | 15099590221997 | 474991 | 474991 | SYNCHRON Systems OP 300 High Urine Control | Synchron | BECKMAN COULTER, INC. |
| 24 | 15099590221270 | 469905 | 469905 | Vigil Lipid Control Level 1 | Vigil | BECKMAN COULTER, INC. |
| 25 | 10851290002567 | CVC 223 | CVC 223 | RNA Medical CVC 223 Multi-Level Carton | RNA Medical | RNA MEDICAL DIVISION |
| 26 | 10851290002550 | CVC 123 | CVC 123 | Carton for CVC 123 | RNA Medical | RNA MEDICAL DIVISION |
| 27 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 28 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 29 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 30 | 10758750008322 | 1009406 | 1009406 | VITROS Immunodiagnostic Products RE Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 31 | 10758750006977 | 6801751 | 6801751 | VITROS Chemistry Products %A1c Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 32 | 10758750006960 | 6801750 | 6801750 | VITROS Chemistry Products %A1c Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 33 | 10758750002702 | 6802349 | 6802349 | VITROS Chemistry Products dTIBC Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 34 | 10758750002696 | 6802348 | 6802348 | VITROS Chemistry Products dTIBC Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 35 | 10627966005305 | C5003-2 | C5003-2 | RAMP® Cardiac Controls - Level 2 | RESPONSE BIOMEDICAL CORP | |
| 36 | 10627966005299 | C5003-1 | C5003-1 | RAMP® Cardiac Controls - Level 1 | RESPONSE BIOMEDICAL CORP | |
| 37 | M52551410 | 5141 | Hi Res Protein Marker | HELENA LABORATORIES CORPORATION | ||
| 38 | M52551360 | 5136 | SPE Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 39 | M52550690 | 5069 | LipoTrol (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
| 40 | M52534250 | 3425 | SPE Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 41 | M52534240 | 3424 | SPE Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 42 | M52518110 | 1811 | V8 SP Abnormal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 43 | M52518100 | 1810 | V8 SP Normal Control (10 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 44 | M52518050 | 1805 | V8 Serum Protein SPE Kit (500 tests) | HELENA LABORATORIES CORPORATION | ||
| 45 | M52514790 | 1479 | Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays | HELENA LABORATORIES CORPORATION | ||
| 46 | 08718734961499 | Level 3 | 221.003.010 | CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
| 47 | 08718734961482 | Level 2 | 221.002.010 | CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
| 48 | 08718734961475 | Level 1 | 221.001.010 | CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
| 49 | 08718734961468 | 220.000.005 | CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 | CueSee® VeriSTAT LVM | EUROTROL B.V. | |
| 50 | 08718734960928 | 183.000.005 | Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. | Eurotrol | EUROTROL B.V. |