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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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Atellica IM aCCP QC - 00630414245676

anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10732999
In Commercial Distribution

  • 00630414245676 ()
10732999

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Atellica IM aCCP - 00630414245669

anti-CCP IgG (aCCP) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10732998
In Commercial Distribution

  • 00630414245669 ()
10732998

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

Dimension Vista T4/TU CAL - 00630414240268

Vista T4/TU CAL
Siemens Healthcare Diagnostics Inc.
11319105
In Commercial Distribution

  • 00630414240268 ()
KC165

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica IM AFP - 00630414238807

Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11202258
In Commercial Distribution

  • 00630414238807 ()
11202258

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Atellica IM AFP - 00630414238791

Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202257
In Commercial Distribution

  • 00630414238791 ()
11202257

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

DM EXL LOCI BRAHMS PCT Cal Kit - 00630414238708

Procalcitonin (PCT) DM EXL LOCI BRAHMS - Cal Kit
Siemens Healthcare Diagnostics Inc.
11354448
In Commercial Distribution

  • 00630414295039 ()
  • 00630414238708 ()
RC648

  • Procalcitonin (PCT) IVD, calibrator

DM EXL LOCI BRAHMS PCT - 00630414238692

Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Siemens Healthcare Diagnostics Inc.
11354447
In Commercial Distribution

  • 00630414298214 ()
  • 00630414238692 ()
RF648

  • Procalcitonin (PCT) IVD, reagent

Atellica CH AMY_2 - 00630414238357

Amylase_2 (AMY_2) Atellica CH - RGT 1050T
Siemens Healthcare Diagnostics Inc.
11097649
In Commercial Distribution

  • 00630414238357 ()
11097649

  • Total amylase IVD, kit, spectrophotometry

Atellica CH TACR - 00630414238340

Tacrolimus (TACR) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097542
In Commercial Distribution

  • 00630414238340 ()
11097542

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

POCcelerator™ SE Data Management System - 00630414238142

No Description
Siemens Healthcare Diagnostics Inc.
10736583
In Commercial Distribution

  • 00630414238142 ()
10736583

  • Medical equipment clinical data interfacing software
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