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 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
VALIDATE THY2 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 instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) 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 UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705ab
In Commercial Distribution

  • 00850011135358 ()

  • 2 tests
705ab

  • Multiple urine analyte 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 Fertility 1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
502ab
In Commercial Distribution

  • 00850011135297 ()

  • 2 tests
502ab

  • Total testosterone IVD, control
  • Prolactin IVD, control
  • Luteinizing hormone (LH) IVD, control
  • Human chorionic gonadotropin beta-subunit (beta-HCG)/follicle stimulating hormone (FSH) 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 Diabetes is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
204ro
In Commercial Distribution

  • 00850011135273 ()

  • 2 tests
204ro

  • Cystatin C IVD, control
  • Insulin IVD, control
  • Beta-hydroxybutyrate IVD, control
  • Fructosamine IVD, control
  • C-peptide 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
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705db
In Commercial Distribution

  • 00850011135129 ()

  • 2 tests
705db

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

  • 00850011135112 ()

  • 2 tests
705bcc

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

  • 00850011135105 ()

  • 2 tests
705au

  • Multiple urine analyte IVD, control
ARCHITECT SHBG Controls
Abbott GmbH
08K2611
In Commercial Distribution

  • 00380740156060 ()
08K2611

  • Sex hormone binding globulin (SHBG) IVD, control
ARCHITECT SHBG Calibrators
Abbott GmbH
08K2602
In Commercial Distribution

  • 00380740156053 ()
08K2602

  • Sex hormone binding globulin (SHBG) IVD, calibrator
ALINITY h-series HemCal
Abbott GmbH
04U7302
In Commercial Distribution

  • 00380740151294 ()
04U7302

  • Full blood count IVD, calibrator
ALINITY h-series CONTROL 29P
Abbott GmbH
04U7212
In Commercial Distribution

  • 00380740151287 ()
04U7212

  • Full blood count IVD, control
ALINITY h-series CONTROL 29P
Abbott GmbH
04U7206
In Commercial Distribution

  • 00380740151270 ()
04U7206

  • Full blood count IVD, control
ARCHITECT B.R.A.H.M.S PCT Controls
Abbott GmbH
06P2210
In Commercial Distribution

  • 00380740138912 ()
06P2210

  • Procalcitonin (PCT) IVD, calibrator
ARCHITECT B.R.A.H.M.S PCT Calibrators
Abbott GmbH
06P2201
In Commercial Distribution

  • 00380740138905 ()
06P2201

  • Procalcitonin (PCT) IVD, calibrator
Alinity s Optics Verifier Kit
Abbott Ireland Diagnostics
01R3565
In Commercial Distribution

  • 00380740136895 ()
01R3565

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
CELL-DYN 22 Plus Calibrator
ABBOTT LABORATORIES
09H73-01
In Commercial Distribution

  • 00380740119843 ()
09H7301

  • Full blood count IVD, calibrator
CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-02
In Commercial Distribution

  • 00380740119836 ()
09H7202

  • Full blood count IVD, control
CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-01
In Commercial Distribution

  • 00380740119829 ()
09H7201

  • Full blood count IVD, control
CELL-DYN 18 PLUS CALIBRATOR
ABBOTT LABORATORIES
09H70-01
In Commercial Distribution

  • 00380740020347 ()
09H7001

  • Full blood count IVD, calibrator
CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-02
In Commercial Distribution

  • 00380740020330 ()
09H6902

  • Full blood count IVD, control
CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-01
In Commercial Distribution

  • 00380740020323 ()
09H6901

  • Full blood count IVD, control
CELL-DYN RETIC PLUS CONTROL
ABBOTT LABORATORIES
08H62-01
In Commercial Distribution

  • 00380740017149 ()
08H6201

  • Reticulocyte count IVD, control
CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-02
In Commercial Distribution

  • 00380740017118 ()
08H5902

  • Full blood count IVD, control
CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-01
In Commercial Distribution

  • 00380740017101 ()
08H5901

  • Full blood count IVD, control
CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-02
In Commercial Distribution

  • 00380740017095 ()
08H5802

  • Full blood count IVD, control
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