No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197006254 | 08688214190 | 08688214190 | QLX | Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA | 2 | cobas® EBV/BKV Control Kit | |
2 | 00875197005998 | 07948352190 | 07948352190 | NPR,NPQ | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR V LEIDEN MUTATIO TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR | 2 | cobas Factor II and Factor V Test | |
3 | 00875197005646 | 07402678190 | 07402678190 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | cobas® Strep A Quality Control Kit for use on the cobas® Liat® System | |
4 | 00875197005363 | 2.0 | 07102577190 | OOI,LSL,MKZ | real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, N real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | cobas® 4800 CT/NG Test v2.0 | |
5 | 00875197005356 | 2.0 | 07102569190 | LSL,MKZ,OOI | DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real ti DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real time Nucleic acid amplification system | 1 | cobas® 4800 CT/NG Test v2.0 | |
6 | 00875197004458 | 1.0 | 06768318190 | OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | cobas® 4800 Systems Internal Control Kit | |
7 | 00875197004427 | 1.0 | 06768172190 | NQX,OOI | SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN,real time Nucleic acid amplification system | 2 | cobas® MRSA/SA Test | |
8 | 00875197004410 | 1.0 | 06768113190 | OOI,NQX | real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION T real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN | 2 | cobas® MRSA/SA Test | |
9 | 00875197004120 | 05985536190 | 05985536190 | OWD | Somatic gene mutation detection system | 3 | cobas® DNA Sample Preparation Kit | |
10 | 00875197003215 | 1.0 | 05235847190 | LSL,OOI,MKZ | DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, N DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | cobas® 4800 System Control Diluent Kit | |
11 | 00875197003185 | 05235804190 | 05235804190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 System Sample Preparation Kit | |
12 | 00875197003178 | 05235782190 | 05235782190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 System Sample Preparation Kit | |
13 | 00875197001983 | 03568555190 | 03568555190 | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test | |
14 | 00875197001068 | 2 | 03302563018 | COBAS® AmpliScreen HCV Test, v2.0 | ||||
15 | 00875197000993 | 2 | 03155935018 | MTL | MONITOR,TEST,HIV-1 | 3 | COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 | |
16 | 08430215046203 | 03531414001 | 03531414001 | OOI | real time Nucleic acid amplification system | 2 | LightCycler® 2.0 Instrument | |
17 | 07613336171295 | 08988218001 | 08988218001 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | cobas® prime Secondary Tube Tray | |
18 | 07613336146644 | 08106568001 | 08106568001 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | AVENIO Millisect | |
19 | 04015630925537 | 03121453001 | 03121453001 | JJF | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE | 1 | COBAS® TaqMan® | |
20 | 00875197006421 | 09040897190 | 09040897190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas® CMV | |
21 | 00875197006131 | 08244049190 | 08244049190 | cobas Babesia | ||||
22 | 00875197005776 | 07460066190 | 07460066190 | MKZ,LSL,OOI | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real ti DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system | 1 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | |
23 | 00875197005752 | 07460155190 | 07460155190 | MAQ | Kit, Dna Detection, Human Papillomavirus | 3 | cobas HPV for use on the cobas 6800/8800 systems | |
24 | 00875197004939 | 07001037190 | 07001037190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas CMV Control Kit | |
25 | 00875197004069 | 2 | 05923450190 | MZF | Test, hiv detection | 2 | COBAS® TaqMan® HIV-1 Test version 2.0, For Use With the High Pure System | |
26 | 00875197004045 | 2.0 | 05969484190 | cobas® TaqScreen MPX Test, v2.0 | ||||
27 | 00875197003260 | 05235898190 | 05235898190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 HPV Amplification/Detection Kit | |
28 | 00875197003253 | 05235880190 | 05235880190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 HPV Amplification/Detection Kit | |
29 | 00875197003024 | 2 | 05212308190 | MZF | Test, hiv detection | 2 | COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0 | |
30 | 00875197002676 | 05002125190 | 05002125190 | cobas® TaqScreen Cadaveric Specimen Diluent Kit | ||||
31 | 00875197002218 | 04404220190 | 04404220190 | cobas® TaqScreen Wash Reagent | ||||
32 | 00875197002003 | 03577163190 | 03577163190 | MKT | Hepatitis Viral B DNA Detection | 3 | COBAS® TaqMan® HBV Test, For Use With The High Pure System | |
33 | 00875197001099 | 2 | 03322114018 | COBAS® AmpliScreen HIV-1 Test, v1.5 | ||||
34 | 00875197000030 | 20759899123 | 20759899123 | COBAS® AMPLICOR Wash Buffer | ||||
35 | 07613336193297 | 09341935001 | 09341935001 | GWW | Ataxiagraph | 1 | Floodlight MS Draw Shape Test | |
36 | 07613336193280 | 09341927001 | 09341927001 | GWW | Ataxiagraph | 1 | Floodlight MS Draw Shape Test | |
37 | 07613336193259 | 09341889001 | 09341889001 | GWW | Ataxiagraph | 1 | Floodlight MS Pinching Test | |
38 | 07613336119563 | 07886977001 | 07886977001 | OOI | real time Nucleic acid amplification system | 2 | cobas Liat Software Version 3.0 | |
39 | 04038377020556 | 03502295001 | 03502295001 | MKT | Hepatitis Viral B DNA Detection | 3 | High Pure System Viral Nucleic Acid Kit | |
40 | 00875197006490 | 09040919190 | 09040919190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas® CMV Control Kit | |
41 | 00875197006483 | 09040536190 | 09040536190 | MZF | Test, HIV detection | 2 | cobas® HIV-1/HIV- 2 192T | |
42 | 00875197006445 | 09051554190 | 09051554190 | MZF | Test, HIV detection | 2 | cobas® NHP Negative Control Kit | |
43 | 00875197006261 | 08688206190 | 08688206190 | QLX | Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA | 2 | cobas® EBV | |
44 | 00875197005264 | 1.0 | 06768253190 | OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | cobas® 4800 System Lysis Kit | |
45 | 00875197004229 | 06471463190 | 06471463190 | OWD | Somatic gene mutation detection system | 3 | cobas® EGFR Mutation Test | |
46 | 00875197004182 | 2 | 05989060190 | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | COBAS® TaqMan® HCV Test For Use With the High Pure System | |
47 | 00875197004137 | 05985579190 | 05985579190 | OWD | Somatic gene mutation detection system | 3 | cobas® 4800 BRAF V600 Mutation Test | |
48 | 00875197002102 | 03599779190 | 03599779190 | COBAS® AmpliScreen HBV Test | ||||
49 | 00875197001051 | 03302555018 | 03302555018 | COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit | ||||
50 | 07613336193273 | 09341919001 | 09341919001 | PTY | Computerized Cognitive Assessment Aid, Exempt | 2 | Floodlight MS Cognitive Test |
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 | 04053228010296 | 2 | 5140-1220 | digene® HC2 GC-ID DNA Test | QIAGEN SCIENCES INC. | |
6 | 04053228010265 | 2 | 5130-1220 | digene® HC2 CT/GC DNA Test | QIAGEN SCIENCES INC. | |
7 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
8 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
9 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
10 | 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 |
11 | 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 |
12 | 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 | |
13 | 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 |
14 | 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 |
15 | 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 |
16 | 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. |
17 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
18 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
19 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
20 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
21 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
22 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
23 | 00884999048171 | 09N26-020 | 09N26-020 | Alinity m IRU Waste Container | Alinity m | ABBOTT MOLECULAR INC. |
24 | 00884999048096 | 09N26-019 | 09N26-019 | Alinity m Sample Rack Holder | Alinity m | ABBOTT MOLECULAR INC. |
25 | 00884999048034 | 08N53-002 | 08N53-002 | Alinity m System | Alinity m | ABBOTT MOLECULAR INC. |
26 | 00884999047907 | 09N20-003 | 09N20-003 | Alinity m Diluent Solution Kit | Alinity m | ABBOTT MOLECULAR INC. |
27 | 00884999047884 | 09N50-001 | 09N50-001 | Alinity m Specimen Dilution Kit I | Alinity m | ABBOTT MOLECULAR INC. |
28 | 00884999047877 | 09N20-001 | 09N20-001 | Alinity m Lysis Solution | Alinity m | ABBOTT MOLECULAR INC. |
29 | 00884999047860 | 09N26-010 | 09N26-010 | Alinity m Integrated Reaction Unit (IRU) | Alinity m | ABBOTT MOLECULAR INC. |
30 | 00884999047853 | 09N26-002 | 09N26-002 | Alinity m Pipette Tips, 1000uL | Alinity m | ABBOTT MOLECULAR INC. |
31 | 00884999047846 | 09N26-001 | 09N26-001 | Allinity m Pipette Tips, 50uL | Alinity m | ABBOTT MOLECULAR INC. |
32 | 00884999047716 | 09N20-004 | 09N20-004 | Alinity m Vapor Barrier Solution | Alinity m | ABBOTT MOLECULAR INC. |
33 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
34 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
35 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
36 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
37 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
38 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
39 | 00884999047679 | 09N12-001 | 09N12-001 | Alinity m Sample Prep Kit 2 | Alinity m | ABBOTT MOLECULAR INC. |
40 | 00884999047501 | 09N26-004 | 09N26-004 | Alinity m CO-RE Tip Sleeve | Alinity m | ABBOTT MOLECULAR INC. |
41 | 00884999047488 | 09N26-003 | 09N26-003 | Alinity m Pipette Tip Adapters | Alinity m | ABBOTT MOLECULAR INC. |
42 | 00884999047464 | 09N26-016 | 09N26-016 | Alinity m Universal Sample Rack | Alinity m | ABBOTT MOLECULAR INC. |
43 | 00884999047457 | 09N26-015 | 09N26-015 | Alinity m Handheld Barcode Scanner | Alinity m | ABBOTT MOLECULAR INC. |
44 | 00884999047440 | 09N26-014 | 09N26-014 | Alinity m Assay Tray Carrier | Alinity m | ABBOTT MOLECULAR INC. |
45 | 00884999047433 | 09N26-013 | 09N26-013 | Alinity m Waste Bottle | Alinity m | ABBOTT MOLECULAR INC. |
46 | 00884999047426 | 09N26-012 | 09N26-012 | Alinity m Waste Box | Alinity m | ABBOTT MOLECULAR INC. |
47 | 00884999046528 | 9K12-04 | 9K12-04 | multi-Collect Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
48 | 00884999046528 | 9K12-04 | 9K12-04 | multi-Collect Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
49 | 00884999046511 | 9K12-03 | 9K12-03 | multi-Collect Specimen Collection Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |
50 | 00884999046511 | 9K12-03 | 9K12-03 | multi-Collect Specimen Collection Specimen Collection Kit | Multi-Collect | ABBOTT MOLECULAR INC. |