Other products from "ABBOTT POINT OF CARE INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00054749005192 03P75-87 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
2 00054749005185 03P75-86 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
3 00054749005208 03P75-88 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
4 00054749005611 02R60-05 I-STAT ALINITY SYSTEM KIT QAT Brain trauma assessment test 2 i-STAT
5 00054749005529 04P75-03 i-STAT 1 Wireless OWD Somatic gene mutation detection system 3 i-STAT
6 00054749005222 03P75-90 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
7 00054749005215 03P75-89 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
8 00054749005161 03P75-84 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
9 00054749005154 03P75-83 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
10 00054749005147 03P75-82 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
11 00054749005123 03P75-81 i-Stat 1 Wireless Analyzer OWD Somatic gene mutation detection system 3 i-STAT
12 00054749005093 03P75-07 i-STAT 1 Wireless OWD Somatic gene mutation detection system 3 i-STAT
13 00054749004973 06P17-26 I-STAT TBI Control L2 JJY Multi-analyte controls, all kinds (assayed) 1 i-STAT
14 00054749004966 06P17-25 I-STAT TBI Control L1 JJY Multi-analyte controls, all kinds (assayed) 1 i-STAT
15 00054749004959 06P17-24 I-STAT TBI Calibration Verification Set JJY Multi-analyte controls, all kinds (assayed) 1 i-STAT
16 00054749004393 02R60-82 I-STAT ALINITY INSTRUMENT (MODEL 500) JGS ELECTRODE, ION SPECIFIC, SODIUM 2 i-STAT
17 00054749004386 02R60-81 I-STAT ALINITY INSTRUMENT (MODEL 500) JGS ELECTRODE, ION SPECIFIC, SODIUM 2 i-STAT
18 00054749004379 02R60-80 I-STAT ALINITY INSTRUMENT (MODEL 500) JGS ELECTRODE, ION SPECIFIC, SODIUM 2 i-STAT
19 00054749003914 04P75-45 04P75-45 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
20 00054749003907 04P75-44 04P75-44 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
21 00054749003891 04P75-43 04P75-43 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
22 00054749003884 04P75-42 04P75-42 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
23 00054749003877 04P75-41 04P75-41 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
24 00054749003860 04P75-40 04P75-40 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
25 00054749003853 04P75-39 04P75-39 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
26 00054749003846 03P75-63 03P75-63 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
27 00054749003839 03P75-62 03P75-62 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
28 00054749003822 03P75-61 03P75-61 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
29 00054749003815 03P75-60 03P75-60 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
30 00054749003808 03P75-59 03P75-59 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
31 00054749003792 03P75-58 03P75-58 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
32 00054749003785 03P75-57 03P75-57 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
33 00054749003778 04P75-38 04P75-38 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
34 00054749003761 04P75-37 04P75-37 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
35 00054749003754 04P75-36 04P75-36 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
36 00054749003747 04P75-35 04P75-35 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
37 00054749003730 04P75-34 04P75-34 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
38 00054749003723 04P75-33 04P75-33 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
39 00054749003716 04P75-32 04P75-32 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
40 00054749003709 04P75-31 04P75-31 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
41 00054749003693 04P75-30 04P75-30 i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
42 00054749003600 04P75-01R 04P75-01R i-STAT 1 Analyzer, Immuno Ready CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
43 00054749003587 03P75-06R 03P75-06R i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
44 00054749003402 03P75-55 03P75-55 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
45 00054749003396 03P75-54 03P75-54 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
46 00054749003389 03P75-53 03P75-53 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
47 00054749003372 03P75-52 03P75-52 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
48 00054749003365 03P75-51 03P75-51 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
49 00054749003358 03P75-50 03P75-50 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
50 00054749003044 03P75-56 03P75-56 i-Stat 1 Wireless Analyzer CGA GLUCOSE OXIDASE, GLUCOSE 2 i-STAT
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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.
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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.
26 00054749005222 03P75-90 i-Stat 1 Wireless Analyzer i-STAT ABBOTT POINT OF CARE INC.
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30 00054749005185 03P75-86 i-Stat 1 Wireless Analyzer i-STAT ABBOTT POINT OF CARE INC.
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