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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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BIPOLAR SEALER 23-112-1 AQM 6.0
MEDTRONIC NAVIGATION, INC.
23-112-1
In Commercial Distribution

  • 00763000047412 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Uric Acid Reagent (URIC 2 x 300)
Beckman Coulter, Inc.
442785
In Commercial Distribution

  • 15099590575281 ()
442785

  • Uric acid IVD, kit, spectrophotometry
The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
Beckman Coulter, Inc.
A85264
In Commercial Distribution

  • 15099590226213 ()
A85264

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
Amphetamines Reagent (AMPH 1 x 250)
Beckman Coulter, Inc.
475000
In Commercial Distribution

  • 15099590222055 ()
475000

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
The Access AMH assay is paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics.
Beckman Coulter, Inc.
B13127
In Commercial Distribution

  • 15099590669263 ()
B13127

  • Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results.
Beckman Coulter, Inc.
B63284
In Commercial Distribution

  • 15099590671495 ()
B63284

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Adult Breathing Circuit
DEROYAL INDUSTRIES, INC.
86-001698
In Commercial Distribution

  • 50749756337972 ()
  • 00749756337977 ()
86-001698

  • Anaesthesia breathing circuit, single-use
Breathing Circuit
DEROYAL INDUSTRIES, INC.
86-001682
In Commercial Distribution

  • 50749756329205 ()
  • 00749756329200 ()
86-001682

  • Anaesthesia breathing circuit, single-use
Anesthesia Breathing Circuit
DEROYAL INDUSTRIES, INC.
86-001673
In Commercial Distribution

  • 50749756322794 ()
  • 00749756322799 ()
86-001673

  • Anaesthesia breathing circuit, single-use
Anesthesia Kit
DEROYAL INDUSTRIES, INC.
86-001669
In Commercial Distribution

  • 50749756305926 ()
  • 00749756305921 ()
86-001669

  • Anaesthesia breathing circuit, single-use
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