Other products from "INVIVOSCRIBE, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00810022731598 810022731598 A1010041 Analyte specific reagent targets the diversity and joining regions of the human Analyte specific reagent targets the diversity and joining regions of the human immunoglobulin heavy chain gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
2 00810022731574 810022731574 A1010031 Analyte specific reagent that targets the framework 3 region of the human immuno Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy chain gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
3 00810022731567 810022731567 A1010030 Analyte specific reagent that targets the framework 3 region of the human immuno Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy chain gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
4 00810022731550 810022731550 A1010020 Analyte Specific Reagent that targets the framework 2 region of the human immuno Analyte Specific Reagent that targets the framework 2 region of the human immunoglobulin heavy chain gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
5 00810022731543 810022731543 A1010011 Analyte specific reagent that targets the framework 1 region of the human immuno Analyte specific reagent that targets the framework 1 region of the human immunoglobulin heavy chain gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
6 00810022731536 810022731536 A1010010 Analyte Specific Reagent that targets the framework 1 region of the human immuno Analyte Specific Reagent that targets the framework 1 region of the human immunoglobulin heavy chain gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
7 00810022731284 810022731824 A4160001 This analyte specific reagent targets the NPM1 gene in Exon 12 MVU Reagents, Specific, Analyte 1 Invivoscribe
8 00810022731277 810022731277 A4120479 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
9 00810022731260 810022731260 A4120469 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
10 00810022731253 810022731253 A4120459 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
11 00810022731246 810022731246 A4120449 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
12 00810022731239 810022731239 A4120439 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
13 00810022731222 810022731222 A4120429 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
14 00810022731215 810022731215 A4120419 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
15 00810022731208 810022731208 A4120409 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
16 00810022731192 810022731192 A4120399 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
17 00810022731185 810022731185 A4120389 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
18 00810022731178 810022731178 A4120379 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
19 00810022731161 810022731161 A4120369 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
20 00810022731154 810022731154 A4120359 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
21 00810022731147 810022731147 A4120349 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
22 00810022731130 810022731130 A4120339 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
23 00810022731123 810022731123 A4120329 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
24 00810022731116 810022731116 A4120319 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
25 00810022731109 810022731109 A4120309 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
26 00810022731093 810022731093 A4120299 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
27 00810022731086 810022731086 A4120289 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
28 00810022731079 810022731079 A4120279 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
29 00810022731062 810022731062 A4120269 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
30 00810022731055 810022731055 A4120259 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
31 00810022731048 810022731048 A4120249 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
32 00810022731031 810022731031 A4120239 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
33 00810022731024 810022731024 A4120229 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
34 00810022731017 810022731017 A4120219 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
35 00810022731000 810022731000 A4120209 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
36 00810022730997 810022730997 A4120199 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
37 00810022730980 810022730980 A4120189 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
38 00810022730973 810022730973 A4120179 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
39 00810022730959 810022730959 A4120159 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
40 00810022730942 810022730942 A4120149 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
41 00810022730935 810022730935 A4120139 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
42 00810022730928 810022730928 A4120129 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
43 00810022730911 810022730911 A4120119 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
44 00810022730898 810022730898 A4120099 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
45 00810022730881 810022730881 A4120089 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
46 00810022730874 810022730874 A4120081 This analyte specific reagent targets the TKD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
47 00810022730867 810022730867 A4120079 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
48 00810022730850 810022730850 A4120071 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
49 00810022730843 810022730843 A4120069 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
50 00810022730829 810022730829 A4120059 This analyte specific reagent targets the ITD analyte within the human FLT3 gene. MVU Reagents, Specific, Analyte 1 Invivoscribe
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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.
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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.