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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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No Description
Biosafe S.A.
Traceability Labels for cryopreservation
Not in Commercial Distribution

  • 07640125650495 ()
7011

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
FB-100.2b
Not in Commercial Distribution

  • 07640125650419 ()
  • 07640125650402 ()
10041

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.2
Not in Commercial Distribution

  • 7640125650396 ()
  • 07640125650389 ()
10032

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.1
Not in Commercial Distribution

  • 07640125650372 ()
  • 07640125650365 ()
10023

  • Blood/tissue storage/culture container
DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures. For use with DG Gel 8 technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
4 x 6 ml
In Commercial Distribution

  • 07640137340605 ()
213285

  • Multiple immunohaematology test IVD, control
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution

  • M5264C23041 ()
  • M5264C23040 ()
  • M5264C23043 ()
4C2304

  • Blood transfer set
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD
IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Bio-Rad Medical Diagnostics GmbH
12008722
In Commercial Distribution

  • 03610522055685 ()
12008722

  • Column agglutination IVD
To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Holding Technologies, LLC
1007
Not in Commercial Distribution

  • B73810071 ()


  • Haematological concentrate system
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