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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 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
The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays.
DRG Instruments Gesellschaft mit beschränkter Haftung
HYB-5252
Not in Commercial Distribution

  • 00404847452525 ()
HYB-5252

  • Nephelometry/turbidimetry analyser IVD, automated/semi-automated
  • Enzyme immunoassay (EIA) analyser IVD
The DRG:HYBRiD-XL® is a fully automated random access analyzer.
DRG Instruments Gesellschaft mit beschränkter Haftung
HYB-5252
In Commercial Distribution

  • 04048474052527 ()
HYB-5252

  • Enzyme immunoassay (EIA) analyser IVD
  • Nephelometry/turbidimetry analyser IVD, automated/semi-automated
The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays.
DRG International Inc
HYB-5252
In Commercial Distribution

  • 00840239052520 ()
HYB-5252

  • Enzyme immunoassay (EIA) analyser IVD
  • Nephelometry/turbidimetry analyser IVD, automated/semi-automated
No Description
GLOBAL SURGICAL CORPORATION
M 528C-MAGE
In Commercial Distribution

  • 00810040250880 ()


  • General-purpose surgical microscope
No Description
NAKANISHI INC.
Surgic Pro2 NON-OPT
In Commercial Distribution

  • 04589551389407 ()


  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered
  • Dental surgical power tool motor, electric
No Description
NAKANISHI INC.
Surgic Pro2 OPT
In Commercial Distribution

  • 04589551389391 ()


  • Foot-switch, electrical
  • Dental surgical power tool motor, electric
  • Surgical power tool system control unit, line-powered
No Description
NAKANISHI INC.
Surgic Pro NON-OPT(120V)
In Commercial Distribution

  • 04560264557567 ()


  • Foot-switch, electrical
  • Dental surgical power tool motor, electric
  • Surgical power tool system control unit, line-powered
No Description
NAKANISHI INC.
Surgic Pro OPT(120V)
In Commercial Distribution

  • 04560264557550 ()


  • Surgical power tool system control unit, line-powered
  • Dental surgical power tool motor, electric
  • Foot-switch, electrical
No Description
NAKANISHI INC.
Surgic Pro+ OPT(120V)
Not in Commercial Distribution

  • 04560264557543 ()


  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered
  • Dental surgical power tool motor, electric
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