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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 CH ALTPLc - 00630414009056

Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097638
In Commercial Distribution

  • 00630414009056 ()
11097638

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

Atellica IM 1300 Analyzer - 00630414007960

Atellica IM 1300 Analyzer
Siemens Healthcare Diagnostics Inc.
11066001
In Commercial Distribution

  • 00630414007960 ()
11066001

  • Chemiluminescent immunoassay analyser IVD

Atellica IM TNIH MCM - 00630414006772

High Sensitivity Troponin I (TnIH) Atellica IM Master Curve Material Kit 5 X 1.0ml
Siemens Healthcare Diagnostics Inc.
10997842
In Commercial Distribution

  • 00630414006772 ()
10997842

  • Troponin I IVD, control

IMMULITE® 2000 TSI CVM - 00630414006680

IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

BN ProSpec® System - 00630414002736

The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
10465217
In Commercial Distribution

  • 00630414002736 ()
OVLI012

  • Nephelometry immunoassay analyser IVD

Atellica CH MULTIDRUG QC - 00630414002699

Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL
Siemens Healthcare Diagnostics Inc.
11099406
Not in Commercial Distribution

  • 00630414002699 ()
  • 00630414211572 ()
11099406

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Atellica Sample Handler Additional - 00630414002460

Atellica SAMPLE HANDLER ADDITIONAL MODULE
Siemens Healthcare Diagnostics Inc.
11069004
In Commercial Distribution

  • 00630414002460 ()
11069004

  • Specimen processing instrument IVD

Atellica Sample Handler Prime - 00630414002439

Atellica SAMPLE HANDLER PRIMARY MODULE
Siemens Healthcare Diagnostics Inc.
11069001
In Commercial Distribution

  • 00630414002439 ()
11069001

  • Specimen processing instrument IVD

Atellica Direct Load Kit - 00630414002354

Atellica DL PRIMARY KIT
Siemens Healthcare Diagnostics Inc.
11068009
In Commercial Distribution

  • 00630414002354 ()
11068009

  • Specimen processing instrument IVD

Atellica Direct Load - 00630414002347

Atellica DL MODULE
Siemens Healthcare Diagnostics Inc.
11068008
In Commercial Distribution

  • 00630414002347 ()
11068008

  • Specimen processing instrument IVD
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