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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 THY 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.
Lgc Clinical Diagnostics, Inc.
901ab
In Commercial Distribution

  • 00850011135723 ()

  • 2 tests
901ab

  • Total cortisol IVD, control
  • Total thyroxine (TT4) IVD, control
  • Free thyroxine (FT4) IVD, control
  • Thyroid stimulating hormone (TSH) IVD, control
  • Total triiodothyronine (TT3) IVD, control
  • Free triiodothyronine (FT3) IVD, control
AccuTrak aTSHR Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0255
In Commercial Distribution

  • 00850011135709 ()


  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
AccuTrak aTPO Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0254
In Commercial Distribution

  • 00850011135693 ()


  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
AccuTrak aTG Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0253
In Commercial Distribution

  • 00850011135686 ()


  • Thyroglobulin antibody IVD, control
VALIDATE Fertility 4 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 analyte: Placental growth factor (PlGF). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 4.0 milliliters. There exists a linear relationship among Levels 1 through 5 for each set.
Lgc Clinical Diagnostics, Inc.
503re
In Commercial Distribution

  • 00850011135679 ()


  • Placental growth factor (PLGF) IVD, control
VALIDATE B-CTx Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
304re
In Commercial Distribution

  • 00850011135662 ()


  • Collagen type I cross-linked C-telopeptide IVD, control
VALIDATE CT Calibration Verification/Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
907re
In Commercial Distribution

  • 00850011135648 ()


  • Calcitonin IVD, control
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
VALIDATE THY2 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: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution

  • 00850011135600 ()


  • Thyroglobulin IVD, control
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