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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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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 V600 gene mutation IVD, kit, nucleic acid technique (NAT)
The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids.
BAXTER HEALTHCARE CORPORATION
955630
In Commercial Distribution

  • 00085412639505 ()
955630

  • Conduction blood/fluid warmer
The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.
BAXTER HEALTHCARE CORPORATION
955516
In Commercial Distribution

  • 37332414123933 ()
  • 07332414123932 ()
955516

  • Conduction blood/fluid warmer set
Positioner - wedge
General Hospital Supply Corp
4411
In Commercial Distribution

  • 10850045406339 ()
  • 00850045406332 ()
4411

  • Freestanding patient positioner, single-use
Positioner - block
General Hospital Supply Corp
495
In Commercial Distribution

  • 10850045406322 ()
  • 00850045406325 ()
495

  • Freestanding patient positioner, single-use
STA Handpiece without needle
Milestone Scientific Inc.
STA-5050A
In Commercial Distribution

  • 20618874000022 ()
  • 00618874128012 ()


  • Dental computer assisted anaesthesia injection handpiece
STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-305
In Commercial Distribution

  • 20618874000053 ()
  • 00618874603052 ()


  • Dental computer assisted anaesthesia injection handpiece
STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-301
In Commercial Distribution

  • 20618874000046 ()
  • 00618874603014 ()


  • Dental computer assisted anaesthesia injection handpiece
STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-2725
In Commercial Distribution

  • 20618874000039 ()
  • 00618874602710 ()


  • Dental computer assisted anaesthesia injection handpiece
STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-305
In Commercial Distribution

  • 10618874000056 ()
  • 00618874603052 ()


  • Dental computer assisted anaesthesia injection handpiece
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