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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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Spectra Optia® - 05020583103009

IDL Set
TERUMO BCT, INC.
10300
In Commercial Distribution

  • 05020583103009 ()
  • 35020583103000 ()


  • Blood transfer set

Spectra Optia® - 05020583101104

Collection Set
TERUMO BCT, INC.
10110
In Commercial Distribution

  • 05020583101104 ()
  • 35020583101105 ()


  • Blood transfer set

Bio-Rad - 00847865018456

MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL
Bio-RAD Laboratories, Inc.
26166
Not in Commercial Distribution

  • 00847865018456 ()

  • Total Volume: 1 Milliliter
26166

  • HIV1/HIV2 antibody IVD, reagent

GS - 00847865013246

GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL
Bio-RAD Laboratories, Inc.
26227
In Commercial Distribution

  • 00847865013246 ()

  • Total Volume: 40 Milliliter
26227

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013222

GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL
Bio-RAD Laboratories, Inc.
26225
In Commercial Distribution

  • 00847865013222 ()

  • Total Volume: 10 Milliliter
26225

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013208

GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26222
In Commercial Distribution

  • 00847865013208 ()

  • Total Volume: 1.5 Milliliter
26222

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865013185

GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL
Bio-RAD Laboratories, Inc.
26220
In Commercial Distribution

  • 00847865013185 ()

  • Total Volume: 1.5 Milliliter
26220

  • HIV1/HIV2 antigen/antibody IVD, control

GS - 00847865010672

GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26223
In Commercial Distribution

  • 00847865010672 ()

  • Total Volume: 1.5 Milliliter
26223

  • HIV1/HIV2 antigen/antibody IVD, control

Bio-Rad - 00847865002745

MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests
Bio-RAD Laboratories, Inc.
25228
Not in Commercial Distribution

  • 00847865002745 ()

  • 50 Tests
25228

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

COBE® Spectra - 05020583719002

Refurbished COBE® Spectra Apheresis System
TERUMO BCT, INC.
71900
Not in Commercial Distribution

  • 05020583719002 ()


  • Blood transfer set
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