Other products from "ABBOTT MOLECULAR INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00884999002180 02J27-095 02J27-095 UroVysion Bladder Cancer Kit NSD Test, fluorescence in situ hybridization (fish), for bladder cancer detection an Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence 3 UroVysion
2 00884999002142 02J27-025 02J27-025 UroVysion Bladder Cancer Kit NSD Test, fluorescence in situ hybridization (fish), for bladder cancer detection an Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence 3 UroVysion
3 00884999002128 02J27-011 02J27-011 ProbeChek UroVysion Bladder Cancer Kit Control Slides OYU Dna-probe kit, human chromosome 2 UroVysion
4 00884999031357 8L49-030 8L49-30 DNA Amp Check PPM General purpose reagent 1 Abbott
5 00884999039278 4J94-23 4J94-23 ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor NHS Assay, genotype, hiv drug resistance, in vitro 2 ViroSeq
6 00884999007475 4J94-93 4J94-93 ViroSeq HIV-1 Genotyping System v2.0 NHS Assay, genotype, hiv drug resistance, in vitro 2 ViroSeq
7 00884999007468 4J94-92 4J94-92 Sequencing Consumables Kit PPM General purpose reagent 1 ViroSeq
8 00884999007420 4J94-73 4J94-73 PCR Cleanup Kit PPM General purpose reagent 1 ViroSeq
9 00884999049130 09N77-055 09N77-055 Abbott Universal Collection Kit QJR Reagents, 2019-novel coronavirus nucleic acid RealTime
10 00884999049109 09N77-095 09N77-095 Abbott RealTime SARS-CoV-2 Amplification Reagent Kit QJR Reagents, 2019-novel coronavirus nucleic acid RealTime
11 00884999049086 09N77-085 09N77-085 Abbott RealTime SARS-CoV-2 Control Kit QJR Reagents, 2019-novel coronavirus nucleic acid RealTime
12 00884999049055 09N77-010 09N77-010 Abbott RealTime SARS-CoV-2 Application CD-ROM QJR Reagents, 2019-novel coronavirus nucleic acid RealTime
13 00884999048478 02J11-057 02J11-057 VP 2000 System Software v2.1 with Protocols USB KEY STAINER, TISSUE, AUTOMATED 1 VP2000
14 00884999048065 06L83-008 06L83-008 Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM MZF Test, HIV detection 2 RealTime
15 00884999047792 08N90-006 08N90-006 Abbott RealTime IDH1m2000rt Application CD-ROM OWD Somatic gene mutation detection system 3 RealTime
16 00884999047358 08N90-090 08N90-090 Abbott RealTime IDH1 Amplification Reagent Kit OWD Somatic gene mutation detection system 3 RealTime
17 00884999047310 02J11-065 02J11-065 VIP 2000 Upgrade Kit KEY STAINER, TISSUE, AUTOMATED 1 VP2000
18 00884999047297 09N21-002 09N21-002 Abbott RealTime CMV m2000 System Combined Application CD-ROM PAB Cytomegalovirus (cmv) dna quantitative assay 3 RealTime
19 00884999047051 08N82-080 Abbott RealTime IDH2 Control Kit OWD Somatic gene mutation detection system 3 RealTime
20 00884999047044 08N82-090 08N82-090 Abbott RealTime IDH2 Amplification Reagent Kit OWD Somatic gene mutation detection system 3 RealTime
21 00884999047037 08N82-001 08N82-001 Abbott RealTime IDH2 m2000rt Application CD-ROM OWD Somatic gene mutation detection system 3 RealTime
22 00884999046603 03L78-061 03L78-061 Abbott Proteinase K Recombinant, PCR Grade PAB Cytomegalovirus (cmv) dna quantitative assay 3 RealTime
23 00884999046528 9K12-04 9K12-04 multi-Collect Specimen Collection Kit LSL,LIO,MKZ DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA Multi-Collect
24 00884999046511 9K12-03 9K12-03 multi-Collect Specimen Collection Specimen Collection Kit MKZ,LIO,LSL DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DEVICE, SPECIMEN COLLECTION,DNA DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DEVICE, SPECIMEN COLLECTION,DNA-REAGENTS, NEISSERIA Multi-Collect
25 00884999046153 02J11-042 02J11-042 VIP 2000 Upgrade 250 mL Basin Kit KEY STAINER, TISSUE, AUTOMATED 1 VP2000
26 00884999046146 02J11-041 02J11-041 VIP 2000 Upgrade 150 mL Basin Kit KEY STAINER, TISSUE, AUTOMATED 1 VP2000
27 00884999046122 02J11-063 02J11-063 VP 2000 Processor, 100V KEY STAINER, TISSUE, AUTOMATED 1 VP2000
28 00884999046115 02J11-062 02J11-062 VP 2000 Processor, 117V KEY STAINER, TISSUE, AUTOMATED 1 VP2000
29 00884999046108 02J11-061 02J11-061 VP 2000 Processor, 230V KEY STAINER, TISSUE, AUTOMATED 1 VP2000
30 00884999045798 09N21-090 09N21-090 Abbott RealTime CMV Amplification Reagent Kit PAB Cytomegalovirus (cmv) dna quantitative assay 3 RealTime
31 00884999045781 09N21-080 09N21-080 Abbott RealTime CMV Control Kit PAB Cytomegalovirus (cmv) dna quantitative assay 3 RealTime
32 00884999045774 09N21-070 09N21-070 Abbott RealTime CMV Calibrator Kit PAB Cytomegalovirus (cmv) dna quantitative assay 3 RealTime
33 00884999042704 06L83-007 06L83-007 Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM MZF Test, hiv detection 2 RealTime
34 00884999042681 04N45-004 04N45-004 Abbott RealTime HCV m2000 System Combined Application CD-ROM 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 RealTime
35 00884999042667 02N43-004 02N43-004 Abbott RealTime HBV m2000 System Combined Application CD-ROM MKT Hepatitis Viral B DNA Detection 3 RealTime
36 00884999042513 08L21-002 08L21-002 Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM OBF Assay, genotyping, hepatitis c virus 2 RealTime
37 00884999038462 2N40-91 2N40-91 Abbott RealTime HBV Amplification Reagent Kit MKT Hepatitis Viral B DNA Detection 3 RealTime
38 00884999038189 08N16-001 08N16-001 VP 2000 Pretreatment Kit OWE Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement 3 VP2000
39 00884999037762 2N43-03 2N43-03 Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0 MKT Hepatitis Viral B DNA Detection 3 RealTime
40 00884999037656 4N45-03 4N45-03 Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0 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 RealTime
41 00884999037595 03N27-51 03N27-51 Abbott VP2000 Processor Operations Manual, Rev. D KEY STAINER, TISSUE, AUTOMATED 1 VP2000
42 00884999037472 06L87-02 06L87-02 Uracil-N-Glycosylase (UNG) MZP,LSL,OBF,MZF,MKZ 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,DNA-REAGENTS, NEISSERIA,Assay, genotyping, hepatitis c virus,Test, hiv detection,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 RealTime
43 00884999037434 1N30-67 1N30-67 Abbott RealTime HCV Including Uracil-N-Glycosylase (UNG) 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 RealTime
44 00884999037427 6L18-67 6L18-67 Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG) MZF Test, hiv detection 2 RealTime
45 00884999037410 8L07-67 8L07-67 Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glyc Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) LIO,MKZ,LSL DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA 1 RealTime
46 00884999037304 6L18-50 6L18-50 Abbott RealTime HIV-1 Amplification Reagent Extended Use MZF Test, hiv detection 2 RealTime
47 00884999037298 8L07-50 8L07-50 Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps LSL,LIO,MKZ DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 RealTime
48 00884999037168 6L83-06 6L83-06 Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0 MZF Test, hiv detection 2 RealTime
49 00884999037113 06L98-05 06L98-05 Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 LSL,LIO,MKZ DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 RealTime
50 00884999036444 08L21-66 08L21-66 Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genot Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genotype II Assay OBF Assay, genotyping, hepatitis c virus 2 RealTime
Other products with the same Product Code "OWD"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 10054749005519 09P31-26 Cartridge, Chem8+ i-STAT ABBOTT POINT OF CARE INC.
2 10054749005502 03P85-51 Cartridge, CG4+ i-STAT ABBOTT POINT OF CARE INC.
3 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
4 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
5 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
6 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
7 04053228002062 1 870121 therascreen® EGFR RGQ PCR Kit QIAGEN GMBH
8 04053228002048 1 870021 therascreen® KRAS RGQ PCR Kit QIAGEN GMBH
9 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
10 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
11 00884999047792 08N90-006 08N90-006 Abbott RealTime IDH1m2000rt Application CD-ROM RealTime ABBOTT MOLECULAR INC.
12 00884999047358 08N90-090 08N90-090 Abbott RealTime IDH1 Amplification Reagent Kit RealTime ABBOTT MOLECULAR INC.
13 00884999047341 08N90-080 08N90-080 Abbott RealTime IDH1 Control Kit RealTime ABBOTT MOLECULAR INC.
14 00884999047051 08N82-080 Abbott RealTime IDH2 Control Kit RealTime ABBOTT MOLECULAR INC.
15 00884999047044 08N82-090 08N82-090 Abbott RealTime IDH2 Amplification Reagent Kit RealTime ABBOTT MOLECULAR INC.
16 00884999047037 08N82-001 08N82-001 Abbott RealTime IDH2 m2000rt Application CD-ROM RealTime ABBOTT MOLECULAR INC.
17 00875197005592 7258321190 07258321190 cobas&#x00AE EZH2 Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
18 00875197005448 2.0 07248563190 cobas® EGFR Mutation Test v2 ROCHE MOLECULAR SYSTEMS, INC.
19 00875197004229 06471463190 06471463190 cobas® EGFR Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
20 00875197004199 1.0 05852170190 cobas® KRAS Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
21 00875197004137 05985579190 05985579190 cobas® 4800 BRAF V600 Mutation Test ROCHE MOLECULAR SYSTEMS, INC.
22 00875197004120 05985536190 05985536190 cobas® DNA Sample Preparation Kit ROCHE MOLECULAR SYSTEMS, INC.
23 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.
24 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.
25 00054749005529 04P75-03 i-STAT 1 Wireless i-STAT ABBOTT POINT OF CARE INC.
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