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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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ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
No Description
SEPTODONT, INC
01C2080
In Commercial Distribution

  • 00303620000857 ()

  • Weight: 4.5 Gram


  • Dental etching solution
  • Dental composite resin
  • Dentine adhesive
No Description
SEPTODONT, INC
01C2030
In Commercial Distribution

  • 00303620000611 ()

  • Total Volume: 5 Milliliter
01C2030

  • Dentine adhesive
Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
PROMEGA CORPORATION
MD2140
In Commercial Distribution

  • 00849811031717 ()
MD2140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)
Growth Hormone 2 Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
511ro
In Commercial Distribution

  • 00850011135808 ()


  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control
AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control
VALIDATE tTau CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
805re
In Commercial Distribution

  • 00850011135785 ()


  • Tau protein IVD, control
VALIDATE pTau181 CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
804re
In Commercial Distribution

  • 00850011135778 ()


  • Tau protein IVD, control
VALIDATE MTX Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
310ro
In Commercial Distribution

  • 00850011135761 ()


  • Methotrexate therapeutic drug monitoring IVD, control
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 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
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
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
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