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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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Typesafe - 10812269031285

Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
4R4750
In Commercial Distribution

  • 00812269031295 ()
  • 10812269031285 ()
  • 00812269031288 ()


  • Blood donor bag segment sampling IVD

Typesafe - 10812269031278

Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
TS500
In Commercial Distribution

  • 20812269031275 ()
  • 10812269031278 ()
  • 00812269031271 ()


  • Blood donor bag segment sampling IVD

Typesafe 2.0 - 10812269031254

Typesafe 2.0 - Quantity 1000
TYPENEX MEDICAL LLC
SP0201QM
In Commercial Distribution

  • 00812269031264 ()
  • 10812269031254 ()
  • 00812269031257 ()


  • Blood donor bag segment sampling IVD

Typesafe 2.0 - 10812269031230

Typesafe 2.0 - Quantity 500
TYPENEX MEDICAL LLC
SP0201QD
In Commercial Distribution

  • 00812269031240 ()
  • 10812269031230 ()
  • 00812269031233 ()


  • Blood donor bag segment sampling IVD

Alere Determine™ HIV–1/2 Ag/Ab Combo Controls - 10811877010347

The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
Not in Commercial Distribution

  • 10811877010347 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010323

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2649
Not in Commercial Distribution

  • 10811877010323 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010293

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
Not in Commercial Distribution

  • 10811877010293 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Elecsys HIV combi PT - 04015630942497

HIV combi PT Elecsys cobas e 100
Roche Diagnostics GmbH
05390095160
In Commercial Distribution

  • 04015630942497 ()
05390095160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Thermo Scientific - 10850685007002

No Description
Thermo Electron LED GmbH
CW3 Cell Washer
Not in Commercial Distribution

  • 10850685007002 ()
75007504

  • Cell washer IVD

Aurix Single Pack Kit - 10852714003122

Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-01
In Commercial Distribution

  • 10852714003122 ()


  • Wound dressing kit, medicated
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