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 - 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)
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 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 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 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 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)
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
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
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
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
APC-handle; 2 buttons for APC 300 / APC 2
Erbe Elektromedizin GmbH
20132-209
In Commercial Distribution

  • 04050147001329 ()
20132-209

  • Inert gas-enhanced electrosurgical handpiece
APC Rack PDU
ALPHATEC SPINE, INC.
AP6015A
In Commercial Distribution

  • 00190376635675 ()


  • Neurological stereotactic surgery system
Coatest APC Resistance
INSTRUMENTATION LABORATORY COMPANY
82 2643 63
Not in Commercial Distribution

  • 08426950060147 ()
82 2643 63

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
CD326 (EpCAM)-APC
IMMUNOTECH
B90408
In Commercial Distribution

  • 15099590678142 ()
B90408

  • Assay development analyte-specific reagent IVD
CD85j(ILT2)-APC
IMMUNOTECH
B30645
In Commercial Distribution

  • 15099590665432 ()
B30645

  • Assay development analyte-specific reagent IVD
CD279(PD-1)-APC
IMMUNOTECH
B30633
In Commercial Distribution

  • 15099590665319 ()
B30633

  • Assay development analyte-specific reagent IVD
IgG1(mouse)-APC
IMMUNOTECH
IM2475U
In Commercial Distribution

  • 15099590217716 ()
IM2475U

  • Assay development analyte-specific reagent IVD
CD158f(KIR2DL5)-APC
IMMUNOTECH
B19716
In Commercial Distribution

  • 15099590211127 ()
B19716

  • Assay development analyte-specific reagent IVD
CD159a(NKG2a)-APC
IMMUNOTECH
A60797
In Commercial Distribution

  • 15099590205683 ()
A60797

  • Assay development analyte-specific reagent IVD
CD158i (KIR2DS4)-APC
IMMUNOTECH
A60796
In Commercial Distribution

  • 15099590205676 ()
A60796

  • Assay development analyte-specific reagent IVD
CD314(NKG2D)-APC
IMMUNOTECH
A22329
In Commercial Distribution

  • 15099590202200 ()
A22329

  • Assay development analyte-specific reagent IVD
IgG2a(mouse)-APC
IMMUNOTECH
A12694
In Commercial Distribution

  • 15099590201593 ()
A12694

  • Assay development analyte-specific reagent IVD
CD278(ICOS)-APC
IMMUNOTECH
B36127
In Commercial Distribution

  • 15099590665814 ()
B36127

  • Assay development analyte-specific reagent IVD
CD274(PD-L1)-APC
IMMUNOTECH
B36126
In Commercial Distribution

  • 15099590665807 ()
B36126

  • Assay development analyte-specific reagent IVD
UPS, 230VOLT, APC 650VA-BK650E
PENTAX OF AMERICA, INC.
1111-1611
In Commercial Distribution

  • 04961333231195 ()


  • Electroglottograph
APC Proimal Femoral Elevator-Small
Avalign Technologies, Inc.
1-342101
In Commercial Distribution

  • 00190776171285 ()


  • Bone lever/elevator, reusable
Coatest APC Resistance V-S
INSTRUMENTATION LABORATORY COMPANY
82 3138 63
In Commercial Distribution

  • 08426950076100 ()
82 3138 63

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
Coatest APC Resistance V
INSTRUMENTATION LABORATORY COMPANY
82 3120 63
In Commercial Distribution

  • 08426950060017 ()
82 3120 63

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
Modified APC Retractor-Double Prong-Wide
Avalign Technologies, Inc.
1-6440
In Commercial Distribution

  • 00190776304089 ()


  • Hand-held surgical retractor, reusable
APC Proximal Femoral Elevator
Avalign Technologies, Inc.
1-342100
In Commercial Distribution

  • 00190776303877 ()


  • Bone lever/elevator, reusable
Anti-TdT APC E17-1519 ASR
Becton, Dickinson And Company
347210
In Commercial Distribution

  • 00382903472109 ()
347210

  • Terminal deoxynucleotidyl transferase (TdT) IVD, antibody
CD9 APC M-L13 ASR
Becton, Dickinson And Company
341638
In Commercial Distribution

  • 00382903416387 ()
341638

  • CD9 cell marker IVD, antibody
CD117 APC 104D2 ASR
Becton, Dickinson And Company
341106
In Commercial Distribution

  • 00382903411061 ()
341106

  • CD117 (c-kit) cell marker IVD, antibody
CD56 APC NCAM16.2 ASR
Becton, Dickinson And Company
341026
In Commercial Distribution

  • 00382903410262 ()
341026

  • CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, antibody
CD45 APC 2D1 ASR
Becton, Dickinson And Company
340942
In Commercial Distribution

  • 00382903409426 ()
340942

  • CD45 leukocyte common antigen cell marker IVD, antibody
CD20 APC L27 ASR
Becton, Dickinson And Company
340940
In Commercial Distribution

  • 00382903409402 ()
340940

  • CD20 cell marker IVD, antibody
CD25 APC 2A3 ASR
Becton, Dickinson And Company
340938
In Commercial Distribution

  • 00382903409389 ()
340938

  • CD25 cell marker IVD, antibody
CD11b APC D12 ASR
Becton, Dickinson And Company
340936
In Commercial Distribution

  • 00382903409365 ()
340936

  • CD11b cell marker IVD, antibody
CD23 APC EBVCS-5 ASR
Becton, Dickinson And Company
340934
In Commercial Distribution

  • 00382903409341 ()
340934

  • CD23 cell marker IVD, antibody
CD22 APC S-HCL-1 ASR
Becton, Dickinson And Company
340932
In Commercial Distribution

  • 00382903409327 ()
340932

  • CD22 cell marker IVD, antibody
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