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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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Glycohemoglobin Bi-Level Controls - 00657498000922

For Use as Human Glycohemoglobin Controls in Quantitative Glycohemoglobin Procedures.
STANBIO LABORATORY, L.P.
0357-201
In Commercial Distribution

  • 00657498000922 ()
0357-201

  • Total haemoglobin (totHb) IVD, control

Glycohemoglobin Pre-Fil - 00657498000915

For the Quantitative Colorimetric Determination of Glycohemoglobin in Whole Blood.
STANBIO LABORATORY, L.P.
P350-050
In Commercial Distribution

  • 00657498000915 ()
P350-050

  • Total haemoglobin (totHb) IVD, kit, spectrophotometry

Glycohemoglobin - 00657498000908

For the Quantitative Colorimetric Determination of Glycohemoglobin in Whole Blood.
STANBIO LABORATORY, L.P.
0350-060
In Commercial Distribution

  • 00657498000908 ()
0350-060

  • Total haemoglobin (totHb) IVD, kit, spectrophotometry

Direct Glycohemoglobin (HbA1c) - 00657498000878

For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood.
STANBIO LABORATORY, L.P.
0360-040
In Commercial Distribution

  • 00657498000878 ()
0360-040

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Glucose Liqui-UV® - 00657498000809

For the Quantitative Determination of Glucose in Serum or Plasma.
STANBIO LABORATORY, L.P.
1060-500
In Commercial Distribution

  • 00657498000809 ()
1060-500

  • Glucose IVD, kit, spectrophotometry

CK Liqui-UV® - 00657498000724

For the Kinetic Quantitative Determination of Creatine Kinase in Serum.
STANBIO LABORATORY, L.P.
2910-430
In Commercial Distribution

  • 00657498000724 ()
2910-430

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

Calcium (Arsenazo) LiquiColor® - 00657498000618

For the Quantitative Colorimetric determination of Total Calcium in serum.
STANBIO LABORATORY, L.P.
0155-225
In Commercial Distribution

  • 00657498000618 ()
0155-225

  • Calcium (Ca2+) IVD, kit, spectrophotometry

a-Amylase LiquiColor® - 00657498000489

For the Quantitative Determination of Amylase in Serum and Urine.
STANBIO LABORATORY, L.P.
2970-430
In Commercial Distribution

  • 00657498000489 ()
2970-430

  • Total amylase IVD, kit, spectrophotometry

GSP Neonatal Thyroxine (T4) kit - 06438147312139

For the quantitative determination of thyroxine (T4) in dried blood.
Wallac Oy
3302-001U
In Commercial Distribution

  • 06438147312139 ()
3302-001U

  • Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay

WaterPAP™ Pro Starter Kit - 00709078013621

WaterPAP™ Pro Starter Kit Product Packaged in a UofU
WESTMED, INC.
WP-7805
Not in Commercial Distribution

  • 10709078013635 ()
  • 00709078013621 ()


  • PEEP valve, single-use
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