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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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The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
401020
In Commercial Distribution

  • 00657498000731 ()
401020

  • Single-channel clinical chemistry analyser IVD, point-of-care
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
The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
STANBIO LABORATORY, L.P.
0230-450
In Commercial Distribution

  • 00657498000588 ()
0230-450

  • Total bilirubin IVD, kit, enzyme spectrophotometry
For the quantitative colorimetric determination of Direct Bilirubin in Serum and Plasma.
STANBIO LABORATORY, L.P.
0235-450
In Commercial Distribution

  • 00657498000564 ()
0235-450

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry
For the Kinetic Quantitative Determination of ALT/ GPT in Serum for Manual and/or Automated Procedures.
STANBIO LABORATORY, L.P.
2930-500
In Commercial Distribution

  • 00657498000472 ()
2930-500

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
For the Kinetic Quantitative Determination of ALT/ GPT in Serum for Manual and/or Automated Procedures.
STANBIO LABORATORY, L.P.
2930-430
In Commercial Distribution

  • 00657498000465 ()
2930-430

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.
STANBIO LABORATORY, L.P.
401010
In Commercial Distribution

  • 00657498000090 ()
  • 00657498001868 ()
401010

  • Single-channel clinical chemistry analyser IVD, point-of-care
For the Kinetic Quantitative Determination of ALT/GPT in Serum and Plasma.
STANBIO LABORATORY, L.P.
S2930-600
In Commercial Distribution

  • 00657498001677 ()
S2930-600

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine.
STANBIO LABORATORY, L.P.
S2910-600
In Commercial Distribution

  • 00657498001653 ()
S2910-600

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
For the Kinetic Quantitative Determination of Urea Nitrogen (BUN) in Serum and Plasma.
STANBIO LABORATORY, L.P.
S2020-600
In Commercial Distribution

  • 00657498001622 ()
S2020-600

  • Urea IVD, kit, enzyme spectrophotometry
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