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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 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
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
Install Kits are unassayed controls intended for use during assay installations for the following analyte: N-Terminal pro hormone Btype Natriuretic Peptide (NTproBNP).
Lgc Clinical Diagnostics, Inc.
C-1001ro
In Commercial Distribution

  • 00850011135570 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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
Toxoplasma IgG Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
803re
In Commercial Distribution

  • 00850011135549 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody 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
VALIDATE 402pf is intended for Calibration Verification / Linearity of cardiac markers in automated instruments.
Lgc Clinical Diagnostics, Inc.
402pf
In Commercial Distribution

  • 00850011135501 ()


  • Multiple-type clinical chemistry analyte profile 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 VIT D Single clinical chemistry analyte IVD, control
Lgc Clinical Diagnostics, Inc.
506ro
In Commercial Distribution

  • 00850011135457 ()


  • Multiple form 25-hydroxy Vitamin D 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
Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control
Lgc Clinical Diagnostics, Inc.
510mm
In Commercial Distribution

  • 00850011135402 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Validate ISX Multiple-type clinical chemistry analyte IVD, control
Lgc Clinical Diagnostics, Inc.
608mm
In Commercial Distribution

  • 00850011135396 ()


  • Multiple human hormone IVD, control
Validate Body Fluids 3 is intended for quantitative determination of Calibration Verification/Linearity on Automated Instruments.
Lgc Clinical Diagnostics, Inc.
207ro
In Commercial Distribution

  • 00850011135389 ()
207ro

  • Cancer antigen 19-9 (CA19-9) IVD, control
  • Carcinoembryonic antigen (CEA) IVD, control
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