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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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Transducer L10-4lap - 00884838061521

No Description
Philips Ultrasound LLC
989605395602
In Commercial Distribution

  • 00884838061521 ()


  • Surgical ultrasound imaging transducer

Transducer L15-7io - 00884838061491

No Description
Philips Ultrasound LLC
989605387852
In Commercial Distribution

  • 00884838061491 ()


  • Surgical ultrasound imaging transducer

UST-5311-TIP - 04573596212691

Probe
FUJIFILM CORPORATION
UST-5311-TIP
In Commercial Distribution

  • 04573596212691 ()


  • Surgical ultrasound imaging transducer

BioPlex 2200 - 00847865010580

Celiac IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010580 ()

  • 1 Each
6652370A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865010573

Celiac IgG Assay Protocol file CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010573 ()

  • 1 Each
6652270A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865003186

Rubella & CMV Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_ V3
Not in Commercial Distribution

  • 00847865003186 ()

  • 1 Each
6653870C

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002479

HSV-1 & HSV-2 Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002479 ()

  • 1 Each
6653370D

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002455

EBV IgM Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
6651370C
In Commercial Distribution

  • 00847865002455 ()

  • 1 Each
6651370C

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002264

MMRV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002264 ()

  • 1 Each
6652470C

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002233

Syphilis IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002233 ()

  • 1 Each
6651470D

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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