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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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BioPlex 2200 - 03610520506349

25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US
BIO-RAD LABORATORIES, INC.
SW4.2 V3
In Commercial Distribution

  • 03610520506349 ()

  • 1 Each
6653775A

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520150269

BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520150269 ()

  • 1 Each
12000671

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

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software

BioPlex 2200 - 00847865012331

ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865012331 ()

  • 1 Each
6651170D

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

BioPlex 2200 - 00847865002448

ANA Screen with MDSS Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
Not in Commercial Distribution

  • 00847865002448 ()

  • 1 Each
6651170C

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

Soprano® 10 Livento® press - 07640173094791

Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic

Phoenix Diagnostics - 00852676007049

Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
PHOENIX DIAGNOSTICS, INC.
3-221
In Commercial Distribution

  • 01085267600704 ()
  • 00852676007049 ()

  • Total Volume: 460 Milliliter


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

BioPlex 2200 - 03610521185987

BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610521185987 ()

  • 1 Each
12006557

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

BioPlex® 2200 - 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520138267

BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520138267 ()

  • 1 Each
12000657

  • Treponema pallidum reagin antibody IVD, reagent
  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
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