No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30816101025092 | MOL1455 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc Kit | ||
2 | 10816101022387 | EL0928 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect ELISA Sample Diluent | ||
3 | 10816101022110 | EL0907 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Cutoff Calibrator | ||
4 | 10816101022103 | EL0906 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Low Positive Control | ||
5 | 10816101022066 | EL0322 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Antigen | ||
6 | 10816101022059 | EL0315 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Positive Control | ||
7 | 30816101025085 | MOL1451 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc | ||
8 | 10816101022165 | EL0916 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Conjugate | ||
9 | 20816101026962 | MOL2655 | Simplexa™ Flu A/B & RSV Direct Gen II | |||||
10 | 20816101025606 | MOL2960 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Simplexa™ C. difficile Positive Control Pack | ||
11 | 20816101025552 | MOL2660 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV Positive Control Pack | ||
12 | 20816101025507 | MOL2150 | MOL2150 | PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 2 | Simplexa™ HSV 1 & 2 Direct | |
13 | 20816101025101 | SC1100 | Simplexa™ Spectral Calibration Panel | |||||
14 | 10816101022356 | EL0405 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - 10X Wash Buffer | ||
15 | 10816101022332 | EL0311 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control | ||
16 | 10816101022301 | EL0105 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Stop Reagent | ||
17 | 10816101022271 | EL0302 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus Conjugate | ||
18 | 10816101022240 | EL1708 | MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | 2 | DxSelect™ Amber Sample Diluent | ||
19 | 10816101022226 | EL1608 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ Sample Diluent | ||
20 | 10816101022097 | EL0905 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG High Positive Control | ||
21 | 10816101020055 | IF0951 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Substrate Slides | ||
22 | 20816101025583 | MOL2975 | OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | Simplexa™ C. difficile Universal Direct | ||
23 | 20816101025576 | MOL2860 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Simplexa™ Group A Strep Positive Control Pack | ||
24 | 20816101025538 | MOL2600 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV | ||
25 | 20816101022155 | EL0910G-5 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
26 | 20816101022148 | EL0910G | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
27 | 10816101025036 | MOL1011-P | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cycler (220V) Pre-Owned | ||
28 | 10816101022349 | EL0351 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Antigen Wells | ||
29 | 10816101022318 | EL0304 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Conjugate | ||
30 | 10816101022295 | EL0009 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Substrate Reagent | ||
31 | 10816101022080 | EL0904 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV ELISA Negative Control | ||
32 | 20816101025613 | MOL5290 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Simplexa™ C.difficile Sample Prep Kit | ||
33 | 20816101025569 | MOL2850 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Simplexa™ Group A Strep Direct | ||
34 | 20816101025521 | MOL2500 | OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 | Simplexa™ Influenza A H1N1 (2009) | ||
35 | 10816101022134 | EL0909 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Low Positive Control | ||
36 | 10816101022127 | EL0908 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG High Positive Control | ||
37 | 10816101020024 | IF0913 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Non-Detectable Control | ||
38 | 10816101020017 | IF0010 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Polyvalent Conjugate | ||
39 | 30816101025078 | MOL1401 | OOI | Real Time Nucleic Acid Amplification System | 2 | Universal Disc | ||
40 | 40816101025082 | MOL1451 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc | ||
41 | 40816101025075 | MOL1400 | OOI | Real Time Nucleic Acid Amplification System | 2 | Universal Disc | ||
42 | 20816101025774 | MOL3650 | PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 2 | Simplexa™ VZV Direct | ||
43 | 20816101025545 | MOL2650 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV Direct | ||
44 | 10816101025005 | MOL1001 | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cyler (110V) | ||
45 | 10816101022363 | EL0901 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 IgG Antigen Wells | ||
46 | 10816101022288 | EL0303 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) | ||
47 | 10816101022172 | EL0917 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Conjugate | ||
48 | 10816101022073 | EL0903 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Cutoff Calibrator | ||
49 | 10816101021038 | IB0910 | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | HSV-1 and HSV-2 Immunoblot IgG Negative Control | ||
50 | 10816101021014 | IB0901 | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips |
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. |