No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08809357178316 | K-4573 | K-4573 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ 48 Viral RNA Kit |
2 | 08809537077750 | A-5030 | JJH | Clinical Sample Concentrator | 1 | ExiPrep™16 Plus | ||
3 | 08809537070188 | A-5250 | JJH | Clinical Sample Concentrator | 1 | ExiPrep™96 Lite | ||
4 | 08809357179498 | K-3617 | K-3617 | 100 test/kit | JJH | Clinical Sample Concentrator | 1 | MagListo™ 5M Viral DNA/RNA Extraction Kit |
5 | 08809537070058 | A-5150 | JJH | Clinical Sample Concentrator | 1 | ExiPrep™48 Dx | ||
6 | 08809357174219 | K-4414 | K-4414 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ Dx Bacteria Genomic DNA Kit |
7 | 08809357178309 | K-4571 | K-4571 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ 48 Viral DNA/RNA Kit |
8 | 08809537070751 | A-2061 | A-2061 | OOI | Real Time Nucleic Acid Amplification System | 2 | Exicycler™ 384 | |
9 | 08809357174196 | K-4411 | K-4411 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ Dx Blood Genomic DNA Kit |
10 | 08809537070065 | A-5050 | JJH | Clinical Sample Concentrator | 1 | ExiPrep™16 Dx | ||
11 | 08809537070034 | A-2060-1 | A-2060-1 | OOI | Real Time Nucleic Acid Amplification System | 2 | Exicycler™ 96 | |
12 | 08809357174233 | K-4418 | K-4418 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ Dx Mycobacteria Genomic DNA Kit |
13 | 08809357179870 | K-4611 | K-4611 | 384 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ 96 Genomic DNA Kit |
14 | 08809357174172 | K-4472 | K-4472 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ Dx Viral DNA Kit |
15 | 08809357174134 | K-4473 | K-4473 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ Dx Viral RNA Kit |
16 | 08809357179481 | K-4614 | K-4614 | 384 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ 96 Viral DNA/RNA Kit |
17 | 08809357174158 | K-4471 | K-4471 | 96 test/kit | JJH | Clinical Sample Concentrator | 1 | ExiPrep™ Dx Viral DNA/RNA Kit |
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. |