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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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RTI Allograft Paste - 00898623002033

Allograft Paste IC 5cc
Rti Surgical, Inc.
802105
In Commercial Distribution

  • 00898623002033 ()


  • Bone matrix implant, human-derived

MicroVue - 30014613335559

MicroVue CIC-C1q Ctrls
QUIDEL CORPORATION
CIC-C1q Controls
In Commercial Distribution

  • 30014613335559 ()
A013

  • Circulating immune complex (CIC) IVD, control

ARROW - 00801902098962

Arrow(R) PICC Kit featuring Chlorag+ard(R) Technology with Pressure Injectable, Blue Flex Tip (R) Catheter
TELEFLEX INCORPORATED
IPN032858
In Commercial Distribution

  • 30801902098963 ()
  • 00801902098962 ()
ASK-45552-RWJ3

  • Centrally-inserted central venous catheter

ARROW - 00801902091628

Arrow(R) PICC Kit featuring Chlorag+ard(R) Technology with Pressure Injectable, Blue Flex Tip (R) Catheter
TELEFLEX INCORPORATED
IPN032857
In Commercial Distribution

  • 30801902091629 ()
  • 00801902091628 ()
ASK-45552-RWJ3

  • Centrally-inserted central venous catheter

Lymphotype HLA-DR/DQ 72 - 07611969952885

for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823102
Not in Commercial Distribution

  • 07611969952885 ()
823102

  • HLA class II antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

VITROS - 10758750033294

VITROS Immunodiagnostic Products BRAHMS PCT Calibrator
ORTHO CLINICAL DIAGNOSTICS
6195575
In Commercial Distribution

  • 10758750033294 ()
  • 20758750033291 ()
6195575

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750032945

VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6905561
In Commercial Distribution

  • 10758750032945 ()
  • 20758750032942 ()
6905561

  • Procalcitonin (PCT) IVD, control

VITROS - 10758750032938

VITROS Immunodiagnostic Products BRAHMS PCT Controls
ORTHO CLINICAL DIAGNOSTICS
6905560
In Commercial Distribution

  • 10758750032938 ()
  • 20758750032935 ()
6905560

  • Procalcitonin (PCT) IVD, control

VITROS - 10758750008728

VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
1286293
In Commercial Distribution

  • 10758750008728 ()
  • 20758750008725 ()
1286293

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Vysis - 00884999027091

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J22-050
In Commercial Distribution

  • 00884999027091 ()
07J22-050

  • Cancer/tumour-associated aneuploidy IVD, probe
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