No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00849811060991 | AS8000 | AS8000 | The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in c The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC 48 Instrument |
2 | 00849811004483 | 08N80-001 | 08N80-001 | Abbott mSample Preparation System DBS Buffer | PPM | General Purpose Reagent | 1 | Abbott mSample Preparation System DBS Buffer Kit |
3 | 00849811064647 | AS1820 | AS1820 | The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from whole human blood samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC Whole Blood DNA Kit |
4 | 00849811051753 | AS1350 | AS1350 | The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of DNA from FFPE (formalin fixed, paraffin embedded) tissue samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC DNA FFPE Kit |
5 | 00849811051739 | AS1410 | AS1410 | The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from whole human blood samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC RNA Blood Kit |
6 | 00849811060960 | AS1780 | AS1780 | The Maxwell® CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit The Maxwell® CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of viral total nucleic acid from human samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC Viral Total Nucleic Acid Purification Kit |
7 | 00849811056857 | MD4140 | MD4140 | Software used to interpret data obtained using the OncoMate MSI Dx Analysis System. | PZJ | Lynch Syndrome Test System | 2 | OncoMate MSI Dx Interpretive Software |
8 | 00849811051777 | AS1321 | AS1321 | The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of genomic DNA from whole human blood samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC Blood DNA Kit |
9 | 00849811031717 | MD2140 | MD2140 | Qualitative multiplex polymerase chain reaction (PCR) test intended to detect th Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections. | PZJ | Lynch Syndrome Test System | 2 | OncoMate MSI Dx Analysis System |
10 | 00849811004452 | 06K12-24 | 06K12-24 | Abbott mSample Preparation System DNA is a nucleic acid extraction system used f Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples. | JJH | Clinical Sample Concentrator | 1 | Abbott mSample Preparation System DNA |
11 | 00849811056864 | MD4150 | MD4150 | Software for installing OncoMate MSI Dx Analysis System assay method on the 3500 Software for installing OncoMate MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer | PZJ | Lynch Syndrome Test System | 2 | OncoMate MSI Dx Assay Installer |
12 | 00849811051340 | AS6000 | AS6000 | The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in comb The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples. | JJH | Clinical Sample Concentrator | 1 | Maxwell® CSC Instrument |
13 | 00849811050619 | MD4850 | MD4850 | Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Spectral calibration standard used with the Applied Biosystems® 3500 Dx Genetic Analyzer to generate a multicomponent matrix that is applied during the subsequent analysis of amplification products from the OncoMate™ MSI Dx Analysis System. | PZJ | Lynch Syndrome Test System | 2 | OncoMate 5C Matrix Standard |
14 | 00849811004636 | 02N77-01 | 02N77-01 | Lysis buffer used to lyse cells for nucleic acid extraction. | PPM | General Purpose Reagent | 1 | Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit |
15 | 00849811004445 | 04J70-24 | 04J70-24 | Abbott mSample Preparation System is a nucleic acid extraction system used for l Abbott mSample Preparation System is a nucleic acid extraction system used for laboratory isolation of RNA from biological samples. | JJH | Clinical Sample Concentrator | 1 | Abbott mSample Preparation System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04719889100010 | MagXtract 3200 | MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes.Product Use Limitations:The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments. | CHROMA ATE | CHROMA ATE INC. | |
2 | 04061839736436 | UFC801096D | Amicon Ultra – 4 | MERCK MILLIPORE LIMITED | ||
3 | 04061839736429 | UFC901024D | Amicon Ultra – 15 | MERCK MILLIPORE LIMITED | ||
4 | 04061839736412 | UFC801024D | Amicon Ultra – 4 | MERCK MILLIPORE LIMITED | ||
5 | 04061839736405 | UFC901096D | Amicon Ultra – 15 | MERCK MILLIPORE LIMITED | ||
6 | 04061839736399 | UFC801008D | Amicon Ultra – 4 | MERCK MILLIPORE LIMITED | ||
7 | 04061839736382 | UFC901008D | Amicon Ultra – 15 | MERCK MILLIPORE LIMITED | ||
8 | 04054839155017 | 9051 | Minicon CS15 | MERCK MILLIPORE LIMITED | ||
9 | 04054839076817 | UFC801096 | Amicon Ultra – 4 | MERCK MILLIPORE LIMITED | ||
10 | 04054839076800 | UFC901008 | Amicon Ultra – 15 | MERCK MILLIPORE LIMITED | ||
11 | 04054839076794 | UFC801024 | Amicon Ultra – 4 | MERCK MILLIPORE LIMITED | ||
12 | 04054839076787 | UFC801008 | Amicon Ultra – 4 | MERCK MILLIPORE LIMITED | ||
13 | 04054839076640 | UFC901096 | Amicon Ultra – 15 | MERCK MILLIPORE LIMITED | ||
14 | 04054839076633 | UFC901024 | Amicon Ultra – 15 | MERCK MILLIPORE LIMITED | ||
15 | 04054839076244 | 9031 | Minicon B15 | MERCK MILLIPORE LIMITED | ||
16 | 04054839076237 | 4307 | Centriprep-30K | MERCK MILLIPORE LIMITED | ||
17 | 04054839076220 | 4305 | Centriprep-10K | MERCK MILLIPORE LIMITED | ||
18 | 04054839076183 | 4306 | Centriprep-30K | MERCK MILLIPORE LIMITED | ||
19 | 04054839076169 | 4304 | Centriprep-10K | MERCK MILLIPORE LIMITED | ||
20 | 04054839076046 | 4104 | Centrifree | MERCK MILLIPORE LIMITED | ||
21 | 04053228039129 | 1 | 9003070 | The QIAcube Connect MDx system is a fully automated, sample preparation system, The QIAcube Connect MDx system is a fully automated, sample preparation system, processing up to 12 samples using silica spin columns technology. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube Connect MDx system for the protocols described in the instructions for use of the respective kits. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAcube Connect IVD system. | QIAcube Connect MDx | QIAGEN GMBH |
22 | 04053228010760 | 1 | 9001492 | EZ1 Advanced XL | QIAGEN GMBH | |
23 | 04053228010753 | 1 | 9001411 | EZ1 Advanced | QIAGEN GMBH | |
24 | 04053228010739 | 1 | 9001297 | QIAsymphony SP | QIAGEN GMBH | |
25 | 04053228010722 | 1 | 9001292 | QIAcube | QIAGEN GMBH | |
26 | 04053228004592 | 1 | 937236 | QIAsymphony DSP DNA Mini Kit | QIAGEN GMBH | |
27 | 04053228004585 | 1 | 937055 | QIAsymphony DSP Virus/Pathogen Midi Kit | QIAGEN GMBH | |
28 | 04053228004578 | 1 | 937036 | QIAsymphony DSP Virus/Pathogen Mini Kit | QIAGEN GMBH | |
29 | 04053228004561 | 3 | 62124 | EZ1 DSP DNA Blood Kit | QIAGEN GMBH | |
30 | 04053228002963 | 1 | 61504 | QIAamp DSP Circulating DNA Kit | QIAGEN GMBH | |
31 | 04053228002918 | 1 | 61904 | QIAamp DSP Viral RNA Mini Kit | QIAGEN GMBH | |
32 | 04053228002901 | 1 | 61704 | QIAamp DSP Virus Spin Kit | QIAGEN GMBH | |
33 | 04053228002895 | 2 | 61304 | QIAamp DSP DNA Mini Kit | QIAGEN GMBH | |
34 | 04053228002871 | 1 | 60404 | QIAamp DSP DNA FFPE Tissue Kit | QIAGEN GMBH | |
35 | 04053228001898 | 1 | 937255 | QIAsymphony DSP DNA Midi Kit | QIAGEN GMBH | |
36 | 04053228001850 | 1 | 937156 | QIAsymphony DSP AXpH DNA Kit | QIAGEN GMBH | |
37 | 04053228000099 | 4 | 62724 | EZ1 DSP Virus Kit | QIAGEN GMBH | |
38 | 04053228000075 | 2 | 61104 | QIAamp DSP DNA Blood Mini Kit | QIAGEN GMBH | |
39 | 04053228000068 | 1 | 60704 | QIAamp DSP Virus Kit | QIAGEN GMBH | |
40 | 04015630929009 | 05200890001 | 05200890001 | cobas x 480 Analyzer | ROCHE MOLECULAR SYSTEMS, INC. | |
41 | 04015630924615 | 03051315001 | 03051315001 | COBAS® AmpliPrep Instrument | ROCHE MOLECULAR SYSTEMS, INC. | |
42 | 03573026616618 | NUCLISENS® easyMAG® Disposables | NUCLISENS EASYMAG DISPOSABLE are intended to be used with NucliSENS easyMAG. | NUCLISENS® easyMAG® Disposables | BIOMERIEUX SA | |
43 | 03573026615253 | EMAG® TIPS 1000µL | Specific tips for eMAG system which is intended for the automated isolation (pur Specific tips for eMAG system which is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use | EMAG® TIPS 1000µL | BIOMERIEUX SA | |
44 | 03573026613358 | 1.3 | EMAG software (virtual) version 1.3 also called SP3 | EMAG | BIOMERIEUX SA | |
45 | 03573026471859 | 418591 | The eMAG platform is intended for the automated isolation (purification and conc The eMAG platform is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use | EMAG® | BIOMERIEUX SA | |
46 | 03573026448301 | 2.1 | EASYMAG SOFTWARE V2.1 : virtual reference | NucliSENS® easyMAG® | BIOMERIEUX SA | |
47 | 01812125010074 | AC043 | AC043 | QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. | Acuitas | OPGEN, INC. |
48 | 00884999046481 | 04J71-80 | 04J71-80 | Master Mix Tubes | m2000 | ABBOTT MOLECULAR INC. |
49 | 00884999046474 | 04J71-20 | 04J71-20 | 5mL Reaction Vessels | m2000 | ABBOTT MOLECULAR INC. |
50 | 00884999046450 | 04J71-10 | 04J71-10 | 1000ul Pipette Tips | m2000 | ABBOTT MOLECULAR INC. |