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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® 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
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.
400400
In Commercial Distribution

  • 00657498000083 ()
400400

  • Single-channel clinical chemistry analyser IVD, point-of-care
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
Stat Profile Prime Plus MicroSensor Card™ 100
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480646045 ()
  • 00385480646048 ()
64604

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus® Flow Path Flush Tool
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 00385480616218 ()
61621

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus MicroSensor Card™ with COOX
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480616154 ()
  • 00385480616157 ()
61615

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus MicroSensor Card™ with COOX (High Volume)
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480616147 ()
  • 00385480616140 ()
61614

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus MicroSensor Card™ with COOX 100
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480616055 ()
  • 00385480616058 ()
61605

  • Single-channel clinical chemistry analyser IVD, point-of-care
Scanner Handheld DS8178 W/Base & Cable Prime Plus
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 00385480596961 ()
59696

  • Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile Prime Plus® Analyzer (Remanufactured)
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480595084 ()
  • 00385480595087 ()
59508

  • Single-channel clinical chemistry analyser IVD, point-of-care
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