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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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VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: total prostate-specific antigen (Total PSA) and free prostate-specific antigen (FPSA).
Lgc Clinical Diagnostics, Inc.
406ab
In Commercial Distribution

  • 00850011135631 ()


  • Total prostate specific antigen (tPSA) IVD, control
  • Free (unbound) prostate specific antigen (fPSA) IVD, control
VALIDATE OCN Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: N-MID Osteocalcin.
Lgc Clinical Diagnostics, Inc.
305re
In Commercial Distribution

  • 00850011135624 ()


  • Osteocalcin IVD, control
Anti-CCP Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
210re
In Commercial Distribution

  • 00850011135594 ()


  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
Install Kits are unassayed controls intended for use during assay installations for the following analyte: free thyroxine (FT4).
Lgc Clinical Diagnostics, Inc.
C-1002ro
In Commercial Distribution

  • 00850011135587 ()


  • Free thyroxine (FT4) IVD, control
Validate LCMS Steroids Test Kit
Lgc Clinical Diagnostics, Inc.
1003ro
In Commercial Distribution

  • 00850011135563 ()


  • Free testosterone IVD, control
  • Aldosterone IVD, control
  • Androstenedione IVD, control
  • Free cortisol/cortisone IVD, control
  • Dehydroepiandrosterone (DHEA) IVD, control
  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
  • Dihydrotestosterone IVD, control
  • Estradiol (oestradiol) (E2) IVD, control
  • 17-Hydroxyprogesterone IVD, control
  • Progesterone IVD, control
Rubella IgG Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
802re
In Commercial Distribution

  • 00850011135518 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
aHBs Calibration Verification / Linearity Test kit
Lgc Clinical Diagnostics, Inc.
801mm
In Commercial Distribution

  • 00850011135495 ()


  • Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control
Validate 1300wa is intended for Calibration Verification/Linearity of general chemistries on automated instruments.
Lgc Clinical Diagnostics, Inc.
1300wa
In Commercial Distribution

  • 00850011135471 ()
1300wa

  • Multiple-type clinical chemistry analyte profile IVD, control
Validate 1100wa is intended for Calibration Verification/Linearity of general chemistries on automated instruments.
Lgc Clinical Diagnostics, Inc.
1100wa
In Commercial Distribution

  • 00850011135464 ()
1100wa

  • Multiple-type clinical chemistry analyte profile IVD, control
VALIDATE Growth Hormone IVD Control
Lgc Clinical Diagnostics, Inc.
508ro
In Commercial Distribution

  • 00850011135440 ()


  • Human growth hormone (HGH) IVD, control
  • Insulin-like growth factor I (IGF1) IVD, control
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