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 00875197002102 03599779190 03599779190 COBAS® AmpliScreen HBV Test
48 00875197001051 03302555018 03302555018 COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit
49 07613336193273 09341919001 09341919001 PTY Computerized Cognitive Assessment Aid, Exempt 2 Floodlight MS Cognitive Test
50 07613336193266 09341897001 09341897001 PTY Computerized Cognitive Assessment Aid, Exempt 2 Floodlight MS Cognitive Test
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15 04053228043560 2 874721 The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR te The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument. therascreen® FGFR RGQ RT-PCR Kit QIAGEN GMBH
16 04053228035725 1 874821 The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitati The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US)instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use. therascreen® BRAF RGQ PCR Kit QIAGEN GMBH
17 04053228034223 V1 873121 The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the d The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment. therascreen® PIK3CA RGQ PCR Kit QIAGEN GMBH
18 04053228034094 V1 874721 The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR te The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument. therascreen® FGFR RGQ RT-PCR Kit QIAGEN GMBH
19 04053228002062 1 870121 therascreen® EGFR RGQ PCR Kit QIAGEN GMBH
20 04053228002048 1 870021 therascreen® KRAS RGQ PCR Kit QIAGEN GMBH
21 03573026559823 1.0 Software used in combination with the THxIDTM- BRAF assay(used to identify patie Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations) THxID™ BRAF BIOMERIEUX SA
22 03573026354909 410697 410697 The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue THxID™-BRAF BIOMERIEUX SA
23 00884999047792 08N90-006 08N90-006 Abbott RealTime IDH1m2000rt Application CD-ROM RealTime ABBOTT MOLECULAR INC.
24 00884999047358 08N90-090 08N90-090 Abbott RealTime IDH1 Amplification Reagent Kit RealTime ABBOTT MOLECULAR INC.
25 00884999047341 08N90-080 08N90-080 Abbott RealTime IDH1 Control Kit RealTime ABBOTT MOLECULAR INC.
26 00884999047051 08N82-080 Abbott RealTime IDH2 Control Kit RealTime ABBOTT MOLECULAR INC.
27 00884999047044 08N82-090 08N82-090 Abbott RealTime IDH2 Amplification Reagent Kit RealTime ABBOTT MOLECULAR INC.
28 00884999047037 08N82-001 08N82-001 Abbott RealTime IDH2 m2000rt Application CD-ROM RealTime ABBOTT MOLECULAR INC.
29 00875197005592 7258321190 07258321190 cobas&#x00AE EZH2 Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
30 00875197005448 2.0 07248563190 cobas® EGFR Mutation Test v2 ROCHE MOLECULAR SYSTEMS, INC.
31 00875197004229 06471463190 06471463190 cobas® EGFR Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
32 00875197004199 1.0 05852170190 cobas® KRAS Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
33 00875197004137 05985579190 05985579190 cobas® 4800 BRAF V600 Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
34 00875197004120 05985536190 05985536190 cobas® DNA Sample Preparation Kit ROCHE MOLECULAR SYSTEMS, INC.
35 00850052003739 850052003739 K4120361 The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test d The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). LeukoStrat INVIVOSCRIBE, INC.
36 00850052003685 850052003685 K4120221 The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to ident The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis. LeukoStrat INVIVOSCRIBE, INC.