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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 Class Implantable

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oncoReveal CDx - 00860001218282

oncoReveal CDx - Kit (Boxes 1 through 4)
Pillar Biosciences, Inc.
HDA-LC-2001-48
In Commercial Distribution

  • 00860001218282 ()
HDA-LC-2001-4

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

PiVAT Software - 00860001218275

The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

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

oncoReveal CDx - 00860001218251

oncoReveal CDx Box 4 of 4. This box contains extra white and orange caps for reagents.
Pillar Biosciences, Inc.
HDA-LC-2001-48-4
In Commercial Distribution

  • 00860001218251 ()
HDA-LC-2001-48-4

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

oncoReveal CDx Box 3 - 00860001218244

oncoReveal CDx Box 3 of 4. This box contains Purification Beads.
Pillar Biosciences, Inc.
HDA-LC-2001-48-3
In Commercial Distribution

  • 00860001218244 ()
HDA-LC-2001-48-3

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

oncoReveal CDx Box 2 - 00860001218237

oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

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

oncoReveal CDx - 00860001218220

oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
Pillar Biosciences, Inc.
HDA-LC-2001-48-1
In Commercial Distribution

  • 00860001218220 ()
HDA-LC-2001-48-1

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

Unimed - 06945664821162

Reusable SpO2 Sensor/超思/Finger clip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410B-96
In Commercial Distribution

  • 06945664821162 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664821155

Reusable SpO2 Sensor/超思/Soft Tip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410S-96
In Commercial Distribution

  • 06945664821155 ()


  • Pulse oximeter probe, reusable

ERBE - 04050147001145

Connect. cable for APC probes APC 2; APC 300; L 2.5 m
Erbe Elektromedizin GmbH
20132-158
In Commercial Distribution

  • 04050147001145 ()

  • Length: 2.500 Meter
20132-158

  • Electrosurgical cable adaptor

ERBE - 04050147000629

Connect. cable for APC applic. APC 2; APC 300; L 2.5 m
Erbe Elektromedizin GmbH
20132-046
In Commercial Distribution

  • 04050147000629 ()

  • Length: 2.500 Meter
20132-046

  • Inert gas-enhanced electrosurgical cable
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