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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 pTau181 Plasma Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
806re
In Commercial Distribution

  • 00850011135754 ()


  • Tau protein IVD, control
Validate LCMS VIT D Test Kit
Lgc Clinical Diagnostics, Inc.
1001ro
In Commercial Distribution

  • 00850011135730 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control
Validate Fertility 3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
505ro
In Commercial Distribution

  • 00850011135365 ()

  • 2 tests
505ro

  • Anti-Mullerian hormone (AMH) IVD, control
  • Sex hormone binding globulin (SHBG) IVD, control
Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
605sa
In Commercial Distribution

  • 00850011135327 ()

  • 2 tests
605sa

  • Glycated haemoglobin (HbA1c) IVD, control
Validate IL-6 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
509ro
In Commercial Distribution

  • 00850011135310 ()

  • 2 tests
509ro

  • Interleukin-6 (IL-6) IVD, control
Validate Fertility 2 is intended for the quantitative determination of Calibration Verification/Linearity of on automated instruments.
Lgc Clinical Diagnostics, Inc.
504ab
In Commercial Distribution

  • 00850011135303 ()

  • 2 tests
504ab

  • Progesterone IVD, control
  • Estradiol (oestradiol) (E2) IVD, control
  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
  • Alpha-fetoprotein (AFP) IVD, control
Validate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
405ab
In Commercial Distribution

  • 00850011135280 ()

  • 2 tests
405ab

  • Troponin T/Troponin I IVD, control
Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
407ab
In Commercial Distribution

  • 00850011135266 ()

  • 2 tests
407ab

  • Cancer antigen 15-3 (CA15-3) IVD, control
  • Cancer antigen 125 (CA125) IVD, control
  • Carcinoembryonic antigen (CEA) IVD, control
  • Cancer antigen 19-9 (CA19-9) IVD, control
Validate PTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
303ro
In Commercial Distribution

  • 00850011135259 ()

  • 2 tests
303ro

  • Parathyroid hormone (PTH) IVD, control
Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
308ab
In Commercial Distribution

  • 00850011135242 ()

  • 2 tests
308ab

  • Ferritin IVD, control
  • Folate (vitamin B9) IVD, control
  • Vitamin B12 IVD, control
Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
308vt
In Commercial Distribution

  • 00850011135235 ()

  • 2 tests
308vt

  • Ferritin IVD, control
  • Folate (vitamin B9) IVD, control
  • Vitamin B12 IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ro
In Commercial Distribution

  • 00850011135228 ()

  • 2 tests
401ro

  • Multiple cardiac marker IVD, control
Validate ACTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
302mm
In Commercial Distribution

  • 00850011135211 ()

  • 2 tests
302mm

  • Adrenocorticotropic hormone (ACTH) IVD, control
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5.
Lgc Clinical Diagnostics, Inc.
409ro
In Commercial Distribution

  • 00850011135204 ()

  • 2 tests
409ro

  • Multiple cardiac marker IVD, control
  • Homocysteine IVD, control
Validate Body Fluids 2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
206ro
In Commercial Distribution

  • 00850011135198 ()

  • 2 tests
206ro

  • Multiple-type clinical chemistry analyte profile IVD, control
  • Multiple clinical chemistry enzyme IVD, control
Validate THY is intended for the determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
901re
In Commercial Distribution

  • 00850011135181 ()

  • 2 tests
901re

  • 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
Validate THY is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
901bc
In Commercial Distribution

  • 00850011135174 ()

  • 2 tests
901bc

  • 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
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705vt
In Commercial Distribution

  • 00850011135150 ()

  • 2 tests
705vt

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705ro
In Commercial Distribution

  • 00850011135143 ()

  • 2 tests
705ro

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705ri
In Commercial Distribution

  • 00850011135136 ()

  • 2 tests
705ri

  • Multiple urine analyte IVD, control
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