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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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Stat Profile Prime Plus MicroSensor Card™ BUN, Creatinine
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 10385480578216 ()
  • 00385480578219 ()
57821

  • Single-channel clinical chemistry analyser IVD, point-of-care
Calibrator Flush Fixture
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 00385480574587 ()
57458

  • Single-channel clinical chemistry analyser IVD, point-of-care
Control Flush Fixture
NOVA BIOMEDICAL CORPORATION
Prime Plus
In Commercial Distribution

  • 00385480574549 ()
57454

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

  • 10385480574003 ()
  • 00385480574006 ()
57400

  • Single-channel clinical chemistry analyser IVD, point-of-care
Electric Wheelchair (Model: JRWD6010)
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
JRWD6010
In Commercial Distribution

  • 06934374100261 ()


  • Multi-terrain sports wheelchair, electric-motor-driven
Electric Wheelchair (Model: JRWD6012)
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
JRWD6012
In Commercial Distribution

  • 06934374100278 ()


  • Multi-terrain sports wheelchair, electric-motor-driven
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
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 Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution

  • 00866489000098 ()
741743

  • Nucleic acid sample preparation instrument IVD, semi-automated
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