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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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5p15.2 Red - 00847627000224

No Description
BIOCARE MEDICAL LLC
CFA7251X
In Commercial Distribution

  • 00847627000224 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000217

No Description
BIOCARE MEDICAL LLC
CFA7251A
In Commercial Distribution

  • 00847627000217 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 10 Green - 00847627000200

No Description
BIOCARE MEDICAL LLC
CFA7200A
In Commercial Distribution

  • 00847627000200 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Gold - 00847627000194

No Description
BIOCARE MEDICAL LLC
CFA7188Y
In Commercial Distribution

  • 00847627000194 ()


  • Nucleic acid hybridization detection IVD, probe

Aptiva® System Cleaning Solution Kit - 00195126000871

The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module (OM) and flush the system.
INOVA DIAGNOSTICS, INC.
AC1003
In Commercial Distribution



  • Instrument/analyser cleaning agent IVD

VITROS - 10758750033560

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199943
In Commercial Distribution

  • 10758750033560 ()
6199943

  • SARS-CoV-2 antigen IVD, control

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 - 10758750033171

VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen)
ORTHO CLINICAL DIAGNOSTICS
691 2263
In Commercial Distribution

  • 10758750033171 ()
  • 20758750033178 ()
691 2263

  • HIV1 antigen 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

VITROS - 10758750002528

VITROS Immunodiagnostic Products Troponin I ES Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802303
In Commercial Distribution

  • 10758750002528 ()
  • 20758750002525 ()
6802303

  • Troponin I IVD, kit, chemiluminescent immunoassay
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