No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884883002524 | 0017 | LAF,DKZ | Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine | 2 | DRI Amphetamines Assay | ||
2 | 00884883001442 | 100088 | DJR | Enzyme Immunoassay, Methadone | 2 | CEDIA Methadone Assay | ||
3 | 00884883012547 | 10016425 | DJR | Enzyme Immunoassay, Methadone | 2 | CEDIA Methadone Assay | ||
4 | 00884883012684 | 10017205 | ORH | Lamotrigine Assay | 2 | QMS Lamotrigine Assay | ||
5 | 00884883011854 | 10015987 | OUF | Everolimus Immunoassay | 2 | QMS Everolimus Assay | ||
6 | 00884883011625 | 10015632 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
7 | 00884883011328 | 0374116 | DLJ | Calibrators, Drug Specific | 2 | QMS Tobramycin Immunoassay Calibrator Set | ||
8 | 00884883011229 | 0373373 | LAS | Drug Specific Control Materials | 1 | QMS Zonisamide Immunoassay Control Set | ||
9 | 00884883010987 | 10014957 | DKB | Calibrators, Drug Mixture | 2 | CEDIA Multi-Drug OFT Control Set | ||
10 | 00884883007529 | 10027482 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS anti-HBs Positive Control | ||
11 | 00884883007512 | 10027481 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS HIV p24 Positive Control | ||
12 | 00884883006966 | 10023647 | QDR | Plazomicin Test System, Immunoassay | 2 | QMS Plazomicin Immunoassay | ||
13 | 00884883006959 | 969035 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix Syphilis | ||
14 | 00884883006546 | 964003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 High Control | ||
15 | 00884883006478 | 964001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 Low Control | ||
16 | 00884883006454 | 963001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HCV Low Control | ||
17 | 00884883006386 | 960041 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix GBS Positive Control | ||
18 | 00884883006027 | 963603 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix BB NAT HBV Positive Control | ||
19 | 00884883005969 | 1388 | DKB | Calibrators, Drug Mixture | 2 | DRI Negative Urine Calibrator | ||
20 | 00884883005891 | 963602 | MYZ | Kit,Test(Donors),For Bloodborne Pathogen | 2 | Acrometrix BB NAT HIV-1 POS. CTRL | ||
21 | 00884883005594 | 0920 | JXM | Enzyme Immunoassay, Benzodiazipine | 2 | DRI Benzodiazepine Serum Tox Assay | ||
22 | 00884883005587 | 0911 | DIS | Enzyme Immunoassay, Barbiturate | 2 | DRI Barbiturate Serum Tox Assay | ||
23 | 00884883005501 | 100282 | JQY | Ph Meter | 1 | DRI pH-Detect pH 3.6 Control Kit | ||
24 | 00884883005174 | 100255 | LAS | Drug Specific Control Materials | 1 | DRI Oxycodone 300 Controls | ||
25 | 00884883005082 | 100117 | DLJ | Calibrators, Drug Specific | 2 | DRI Methadone Metabolite 150 ng/mL Calibrator | ||
26 | 00884883004771 | 1732153 | DLJ | Calibrators, Drug Specific | 2 | CEDIA LSD Cutoff Calibrator | ||
27 | 00884883004399 | 10014182 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
28 | 00884883004382 | 10014181 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
29 | 00884883004375 | 10014180 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
30 | 00884883004368 | 10014179 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
31 | 00884883004337 | 1815296 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDUA DAU Opiate 2K | ||
32 | 00884883004160 | 024227 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
33 | 00884883004153 | 024224 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
34 | 00884883004108 | 1661248 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDIA DAU Opiate | ||
35 | 00884883003798 | CHU-SP | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS® ChemTRAK H Unassayed Control Sample Pack | ||
36 | 00884883003637 | LG-S1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
37 | 00884883003613 | CAI-XLS | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
38 | 00884883003606 | CAI-XL4 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
39 | 00884883003477 | 100248 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
40 | 00884883003415 | 0514 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
41 | 00884883003347 | 10013878 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
42 | 00884883003330 | 10013877 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
43 | 00884883003323 | 10013876 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
44 | 00884883002968 | 100249 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
45 | 00884883002937 | 0515 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
46 | 00884883002920 | 100116 | DJR | Enzyme Immunoassay, Methadone | 2 | DRI Methadone Metabolite Assay | ||
47 | 00884883002401 | LIG-303 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
48 | 00884883002395 | LIG-202 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
49 | 00884883002388 | LIG-101 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
50 | 00884883002371 | CAI-XLL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control |
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. |