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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1 00628055344179 410400 410400 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automa The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The Revogene Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. Revogene® Strep A MERIDIAN BIOSCIENCE CANADA INC
2 00628055344162 410500 410500 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualita The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms.The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. Revogene® Carba C MERIDIAN BIOSCIENCE CANADA INC
3 00628055344131 610208 610208 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. MOCK PIE MERIDIAN BIOSCIENCE CANADA INC
4 00628055344117 410200 410200 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene® GBS LB MERIDIAN BIOSCIENCE CANADA INC
5 00628055344100 610210 610210 The Revogene® instrument is intended for in vitro diagnostic (IVD) use in perfor The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR. Revogene® MERIDIAN BIOSCIENCE CANADA INC
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7 00628055344070 133499 133499 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitativ The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. GenePOC™ Carba GENEPOC INC
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