No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10190302017336 | A51222 | OOI | real time Nucleic acid amplification system | 2 | Applied Biosystems | ||
2 | 10190302000840 | 6431 | PFF | High throughput DNA sequence analyzer | 2 | Ion PGM™ Dx Chip Minifuge | ||
3 | 10190302005937 | 4405182 | PCA | DNA genetic analyzer | 2 | 3500 Dx Genetic Analyzer | ||
4 | 10190302016162 | A51197 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio™ 7 Pro Dx 96-Well Heated Cover | ||
5 | 10190302000710 | 4478552 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with Cy®5 Dye | ||
6 | 10190302000512 | 9911 | OUL | Thermocycler, generic | 1 | Veriti™ Dx 96-Well Fast Thermal Cycler | ||
7 | 10190302000420 | 4432632 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with TAMRA™ Dye | ||
8 | 10190302000390 | 4432614 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with ROX™ Dye | ||
9 | 10190302000222 | 7503 | NSU | Instrumentation for clinical multiplex test systems | 2 | 7500 Fast Dx Real-Time PCR Instrument | ||
10 | 10190302015592 | A47324 | OOI | real time Nucleic acid amplification system | 2 | Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR System | ||
11 | 10190302000673 | 4462113 | PCA | DNA genetic analyzer | Sequencing Standard v1.1, 3500 Dx Series | |||
12 | 10190302000383 | 4432607 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with VIC™ Dye | ||
13 | 10190302000369 | 4432593 | OOI | real time Nucleic acid amplification system | 2 | RNase P 96-Well Instrument Verification Plate | ||
14 | 10190302007399 | 4452205 | VIIA 7 DX ARRAY CARD BUCKET | OUL | Thermocycler, generic | 1 | Array Card Clip | |
15 | 10190302000659 | 3500xLDxCS2 | PCA | DNA genetic analyzer | 2 | 3500 xL Dx CS2 Genetic Analyzer 24-capillary | ||
16 | 10190302000598 | 7821 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Block | ||
17 | 10190302016940 | A52439 | OOI | real time Nucleic acid amplification system | 2 | 384-Well Spectral Calibration Plate 1 | ||
18 | 10190302017329 | A51220 | OOI | real time Nucleic acid amplification system | 2 | Applied Biosystems | ||
19 | 10190302016148 | A50745 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio™ 7 Pro Dx Real-Time PCR System | ||
20 | 10190302000765 | 4481308 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Background Calibration Plate | ||
21 | 10190302003353 | A31909 | OOI | real time Nucleic acid amplification system | 2 | 96-Well 0.2-mL Calibration Plate 3 (TAMRA, NED, and Cy 5 dyes) | ||
22 | 10190302000529 | 9912 | OUL | Thermocycler, generic | 1 | Veriti™ Dx 96-Well Thermal Cycler | ||
23 | 10190302000468 | 4432656 | OOI | real time Nucleic acid amplification system | 2 | Rnase P Fast 96-Well Instrument Verification Plate | ||
24 | 10190302000413 | 4432626 | OOI | real time Nucleic acid amplification system | 2 | 96-Well Region of Interst and Background Plates | ||
25 | 10190302016964 | A52440 | OOI | real time Nucleic acid amplification system | 2 | 384-Well Spectral Calibration Plate 2 | ||
26 | 10190302016155 | A51195 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio™ 7 Pro Dx 96-Well Block | ||
27 | 10190302000833 | 7469 | PFF | High throughput DNA sequence analyzer | 2 | Personal Genome Machine™ Dx (PGM™) Dx | ||
28 | 10190302003124 | A31908 | OOI | real time Nucleic acid amplification system | 2 | 96-Well 0.2-mL Calibration Plate 2 (ABY, JUN, and MUSTANG PURPLE dyes) | ||
29 | 10190302000536 | 9913 | OUL | Thermocycler, generic | 1 | Veriti™ Dx 384-Well Thermal Cycler | ||
30 | 10190302000697 | 8788 | OOI | real time Nucleic acid amplification system | 2 | QuantStudioTM Dx Real-Time PCR Instrument | ||
31 | 10190302000642 | 3500DxCS2 | PCA | DNA genetic analyzer | 2 | 3500 Dx CS2 Genetic Analyzer 8-capillary | ||
32 | 10190302000611 | 7831 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Heater Cover | ||
33 | 10190302000505 | 4443774 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Normalization Plates with FAM™/ROX™ and VIC™/ROX™ Dyes | ||
34 | 10190302000437 | 4432638 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Region of Interest (ROI) and Background Plates | ||
35 | 10190302000321 | 4432500 | OOI | real time Nucleic acid amplification system | 2 | Rnase P Fast 384-Well Instrument Verification Plate | ||
36 | 10190302000314 | 4432482 | OOI | real time Nucleic acid amplification system | 2 | 384-Well Region of Interest and Background Plates | ||
37 | 10190302000864 | ONE TOUCH ES DX | PFF | High throughput DNA sequence analyzer | 2 | Ion One Touch™ ES Dx | ||
38 | 10190302005944 | 4405183 | PCA | DNA genetic analyzer | 2 | 3500xL Dx Genetic Analyzer | ||
39 | 10190302000734 | 4480914 | OOI | real time Nucleic acid amplification system | 2 | Lamp, Halogen RC, IVD | ||
40 | 10190302000857 | ONE TOUCH DX | PFF | High throughput DNA sequence analyzer | 2 | Ion One Touch™ Dx | ||
41 | 10190302001304 | A31907 | OOI | real time Nucleic acid amplification system | 2 | 96-Well 0.2-mL Calibration Plate 1 (FAM, VIC, ROX, and SYBR dyes) | ||
42 | 10190302006736 | 1.0.1 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio Dx Emerging Pathogens Edition Software Version 1.0.1 | ||
43 | 10190302005654 | A33178 | PFF | High throughput DNA sequence analyzer | 2 | Torrent Suite™ Dx SW, V5.6.4 | ||
44 | 10190302000376 | 4432600 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with FAM™ Dye |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04053228033936 | v1 | 9002824 | Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-D Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-Dx Operational ModuleDI Numbers:QIAstat-Dx Analytical Module DI Number: 04053228033929QIAstat-Dx Operational Module DI Number: 04053228033936 | QIAstat-Dx® Analyzer 1.0 | QIAGEN GMBH |
2 | 04053228033905 | V1 | 691221 | QIAstat-Dx® Respiratory Panel | QIAGEN GMBH | |
3 | 04053228010838 | 1 | 9002035 | Rotor-Gene® Q MDx | QIAGEN GMBH | |
4 | 04053228010746 | 1 | 9001301 | QIAsymphony AS | QIAGEN GMBH | |
5 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
6 | 03661540951947 | RTK403ING | RTK403ING | The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) base The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. | HSV 1&2 ELITe MGB Assay for CE-IVD | ELITECHGROUP MDX LLC |
7 | 03661540900051 | F2102-000 | F2102-000 | The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides dispos The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K).ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay. | ELITe InGenius® Waste Box | ELITECHGROUP SPA |
8 | 03661540900044 | INT032CS | The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides con The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay | ELITe InGenius® SP 200 Consumable Set | ELITECHGROUP SPA | |
9 | 03661540900037 | INT035PCR | INT035PCR | The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides con The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides consumables to be used in association with the ELITe InGenius® instrument (catalog number INT030-K) for Real Time PCR reactions. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® PCR Cassette is FDA cleared only for use in association with HSV1&2 ELITe MGB® Assay. | ELITe InGenius® PCR cassette | ELITECHGROUP SPA |
10 | 03661540900020 | INT032SP200 | INT032SP200 | The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performingextraction, purification, amplification and detection.ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&2 ELITe MGB® Assay. | ELITe InGenius® SP 200 | ELITECHGROUP SPA |
11 | 03661540900006 | INT030-K | INT030-K | The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that perform The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay | ELITe InGenius® | ELITECHGROUP SPA |
12 | 01812125010067 | AC042 | AC042 | QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. | Acuitas | OPGEN, INC. |
13 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
14 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
15 | 00884999048171 | 09N26-020 | 09N26-020 | Alinity m IRU Waste Container | Alinity m | ABBOTT MOLECULAR INC. |
16 | 00884999048096 | 09N26-019 | 09N26-019 | Alinity m Sample Rack Holder | Alinity m | ABBOTT MOLECULAR INC. |
17 | 00884999048034 | 08N53-002 | 08N53-002 | Alinity m System | Alinity m | ABBOTT MOLECULAR INC. |
18 | 00884999047907 | 09N20-003 | 09N20-003 | Alinity m Diluent Solution Kit | Alinity m | ABBOTT MOLECULAR INC. |
19 | 00884999047884 | 09N50-001 | 09N50-001 | Alinity m Specimen Dilution Kit I | Alinity m | ABBOTT MOLECULAR INC. |
20 | 00884999047877 | 09N20-001 | 09N20-001 | Alinity m Lysis Solution | Alinity m | ABBOTT MOLECULAR INC. |
21 | 00884999047860 | 09N26-010 | 09N26-010 | Alinity m Integrated Reaction Unit (IRU) | Alinity m | ABBOTT MOLECULAR INC. |
22 | 00884999047853 | 09N26-002 | 09N26-002 | Alinity m Pipette Tips, 1000uL | Alinity m | ABBOTT MOLECULAR INC. |
23 | 00884999047846 | 09N26-001 | 09N26-001 | Allinity m Pipette Tips, 50uL | Alinity m | ABBOTT MOLECULAR INC. |
24 | 00884999047716 | 09N20-004 | 09N20-004 | Alinity m Vapor Barrier Solution | Alinity m | ABBOTT MOLECULAR INC. |
25 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
26 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
27 | 00884999047679 | 09N12-001 | 09N12-001 | Alinity m Sample Prep Kit 2 | Alinity m | ABBOTT MOLECULAR INC. |
28 | 00884999047501 | 09N26-004 | 09N26-004 | Alinity m CO-RE Tip Sleeve | Alinity m | ABBOTT MOLECULAR INC. |
29 | 00884999047488 | 09N26-003 | 09N26-003 | Alinity m Pipette Tip Adapters | Alinity m | ABBOTT MOLECULAR INC. |
30 | 00884999047464 | 09N26-016 | 09N26-016 | Alinity m Universal Sample Rack | Alinity m | ABBOTT MOLECULAR INC. |
31 | 00884999047457 | 09N26-015 | 09N26-015 | Alinity m Handheld Barcode Scanner | Alinity m | ABBOTT MOLECULAR INC. |
32 | 00884999047440 | 09N26-014 | 09N26-014 | Alinity m Assay Tray Carrier | Alinity m | ABBOTT MOLECULAR INC. |
33 | 00884999047433 | 09N26-013 | 09N26-013 | Alinity m Waste Bottle | Alinity m | ABBOTT MOLECULAR INC. |
34 | 00884999047426 | 09N26-012 | 09N26-012 | Alinity m Waste Box | Alinity m | ABBOTT MOLECULAR INC. |
35 | 00884999043503 | 08N89-001 | 08N89-001 | m2000rt SYSTEM SOFTWARE Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
36 | 00884999043497 | 08N88-001 | 08N88-001 | m2000sp SYSTEM SOFTWARE, Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
37 | 00884999032064 | 9K32-01 | 9K32-01 | Adhesive Cover Applicator | m2000 | ABBOTT MOLECULAR INC. |
38 | 00884999032057 | 9K31-01 | 9K31-01 | Splash Free Support Base | m2000 | ABBOTT MOLECULAR INC. |
39 | 00884999031814 | 9K15-01 | 9K15-01 | m2000rt Instrument System | m2000 | ABBOTT MOLECULAR INC. |
40 | 00884999006577 | 04J71-93 | 04J71-93 | Abbott m2000rt Optical Calibration Kit | m2000 | ABBOTT MOLECULAR INC. |
41 | 00884999006539 | 4J71-75 | 4J71-75 | Optical Adhesive Cover | m2000 | ABBOTT MOLECULAR INC. |
42 | 00884999006522 | 4J71-70 | 4J71-70 | 96-Well Optical Reaction Plate | m2000 | ABBOTT MOLECULAR INC. |
43 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
44 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
45 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
46 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
47 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
48 | 00875197005660 | 07402759190 | 07402759190 | cobas Liat Cleaning Tool | ROCHE MOLECULAR SYSTEMS, INC. | |
49 | 00875197005653 | 07402686190 | 07402686190 | cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
50 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. |