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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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Syva® Emit® Calibrator/Control Level 0 (negative) - 00842768001734

Syva® Emit® Calibrator/Control Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445406
In Commercial Distribution

  • 00842768001734 ()
9A509UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator Level 0 (negative) - 00842768001703

Syva® Emit® Calibrator Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445403
In Commercial Distribution

  • 00842768001703 ()
9A049UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® 2000 Tacrolimus Calibrators - 00842768001680

Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Tacrolimus Assay - 00842768001666

Syva® Emit® 2000 Tacrolimus Assay
Siemens Healthcare Diagnostics Inc.
10445397
In Commercial Distribution

  • 00842768001666 ()
8R019UL

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

Syva® Emit® tox™ Salicylic Acid Calibrators - 00842768001628

Syva® Emit® tox Salicylic Acid Calibrators
Siemens Healthcare Diagnostics Inc.
10445393
In Commercial Distribution

  • 00842768001628 ()
7S109UL

  • Salicylate IVD, calibrator

Syva® Emit® tox™ Salicylic Acid Assay - 00842768001611

Syva® Emit® tox Salicylic Acid Assay
Siemens Healthcare Diagnostics Inc.
10445392
In Commercial Distribution

  • 00842768001611 ()
7S019UL

  • Salicylate IVD, kit, enzyme immunoassay (EIA)

ATELLICA IM ELF KIT - 00630414618463

ATELLICA IM ELF KIT
Siemens Healthcare Diagnostics Inc.
11208118
In Commercial Distribution

  • 00630414618463 ()
11208118

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay

ADVIA CENTAUR ELF KIT - 00630414618128

ADVIA CENTAUR ELF KIT
Siemens Healthcare Diagnostics Inc.
11207300
In Commercial Distribution

  • 00630414618128 ()
11207300

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay

PowerLook AMP SLD Siemens - 00858012005038

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005038 ()
DSC010-03-US

  • Basic diagnostic x-ray system application software

NPS2 Siemens/Dräger Infinity - 04057834025804

No Description
RAUMEDIC AG
092627-001
In Commercial Distribution

  • 04057834025804 ()


  • Intracranial/compartmental-pressure monitor calibrator/cable
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