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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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Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLA
In Commercial Distribution

  • 00817439020826 ()
HCGCTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 mL.
Medtest Dx, Inc.
HCG-CTL
In Commercial Distribution

  • 00817439020819 ()
HCG-CTL

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
VITROS Immunodiagnostic Products Troponin I ES Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802303
In Commercial Distribution

  • 10758750002528 ()
  • 20758750002525 ()
6802303

  • Troponin I IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199950
In Commercial Distribution

  • 10758750033591 ()
6199950

  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay
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 Immunodiagnostic Products BRAHMS PCT Calibrator
ORTHO CLINICAL DIAGNOSTICS
6195575
In Commercial Distribution

  • 10758750033294 ()
  • 20758750033291 ()
6195575

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
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 Immunodiagnostic Products BRAHMS PCT Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6905561
In Commercial Distribution

  • 10758750032945 ()
  • 20758750032942 ()
6905561

  • Procalcitonin (PCT) IVD, control
VITROS Immunodiagnostic Products BRAHMS PCT Controls
ORTHO CLINICAL DIAGNOSTICS
6905560
In Commercial Distribution

  • 10758750032938 ()
  • 20758750032935 ()
6905560

  • Procalcitonin (PCT) IVD, control
VITROS Immunodiagnostic Products NT-proBNP II Controls
ORTHO CLINICAL DIAGNOSTICS
6844507
In Commercial Distribution

  • 10758750032099 ()
  • 20758750032096 ()
6844507

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
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