Other products from "ROCHE MOLECULAR SYSTEMS, INC."
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&#x00AE 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&#x00AE 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&#x00AE 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
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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.
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25 00884999048034 08N53-002 08N53-002 Alinity m System Alinity m ABBOTT MOLECULAR INC.
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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.
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