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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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Ready Sensor™ Glucose Biosensor - 00630414112343

In vitro diagnostics medical device. For measurement of glucose in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10320748
In Commercial Distribution

  • 00630414112343 ()
  • 00630414009469 ()
476378

  • Laboratory pH electrode

Ready Sensor™ GOLD Chloride Sensor - 00630414112251

Ready Sensor™ Chloride Biosensor for use on the RapidLab® 348/348ex instruments
Siemens Healthcare Diagnostics Inc.
10330133
In Commercial Distribution

  • 00630414112251 ()
  • 00630414010151 ()
476279

  • Chloride (Cl-) electrode IVD

ADVIA Chemistry Enzymatic Hemoglobin A1c - 00630414002859

ADVIA A1c_E Reagent (Small Kit), 300 tests
Siemens Healthcare Diagnostics Inc.
10720857
In Commercial Distribution

  • 00630414002859 ()
10720857

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

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 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

Atellica CH 930 Analyzer - 00630414002163

Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics Inc.
11067000
In Commercial Distribution

  • 00630414002163 ()
11067000

  • Multiple clinical chemistry analyser IVD, laboratory

Atellica IM 1600 Analyzer - 00630414002026

Atellica IM 1600 Analyzer
Siemens Healthcare Diagnostics Inc.
11066000
In Commercial Distribution

  • 00630414002026 ()
11066000

  • Chemiluminescent immunoassay analyser IVD
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