SEARCH RESULTS FOR: UED在线平台链接【上级Q：4120051】.wrn(3242 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Welch Allyn, Inc. - 00732094312706

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312706 ()
QS-6FC-DDBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263497

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263497 ()
QS-6CC-DFCAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094312737

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q- Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 25" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312737 ()
QS-6CC-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer

Hybrid 3D - 00859873006042

Provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function.
Hermes Medical Solutions AB
1.0
Not in Commercial Distribution

  • 00859873006042 ()
P54

  • Nuclear medicine system workstation

Welch Allyn, Inc. - 00732094355222

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; International power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DI
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355222 ()
QS-6ED-DGEAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094307818

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; No power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + X
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094307818 ()
QS-6IA-XGDAA

  • Cardiopulmonary stress exercise monitoring system computer

Hybrid 3D - 00859873006073

Provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function. UDI = 00859873006073 applies to Hybrid 3D version 2.x and 3.x.
Hermes Medical Solutions AB
2.2 and 3.0
In Commercial Distribution

  • 00859873006073 ()
P54

  • Nuclear medicine system workstation

therascreen® BRAF RGQ PCR Kit - 04053228035725

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.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228035725 ()
874821

  • BRAF gene mutation IVD, kit, nucleic acid technique (NAT)

therascreen® PDGFRA RGQ PCR Kit - 04053228034834

The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a realtime qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue. The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT™ (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228034834 ()
874921

  • Gastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT)

therascreen® FGFR RGQ RT-PCR Kit - 04053228043560

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.
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228043560 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
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