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 Class Implantable

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ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD
Aspartate Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097639
In Commercial Distribution

  • 00630414009063 ()
11097639

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097638
In Commercial Distribution

  • 00630414009056 ()
11097638

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
6 vials of 1 calibrator level
Siemens Healthcare Diagnostics Inc.
10916059
In Commercial Distribution

  • 00630414008981 ()
10916059

  • Total creatine kinase (CK) IVD, calibrator
Enzyme 2 Calibrator - ADVIA Chemistry (ENZ 2 CAL)
Siemens Healthcare Diagnostics Inc.
10916058
In Commercial Distribution

  • 00630414008974 ()
10916058

  • Multiple clinical chemistry enzyme IVD, calibrator
Enzyme 1 Calibrator - ADVIA Chemistry (ENZ 1 CAL)
Siemens Healthcare Diagnostics Inc.
10916057
In Commercial Distribution

  • 00630414008967 ()
10916057

  • Multiple clinical chemistry enzyme IVD, calibrator
ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc
Siemens Healthcare Diagnostics Inc.
10729782
In Commercial Distribution

  • 00630414306193 ()
  • 00630414008950 ()
10729782

  • Multiple clinical chemistry enzyme IVD, reagent
4 wedges per reagent , 2 reagent, 1100 test per carton
Siemens Healthcare Diagnostics Inc.
10729780
In Commercial Distribution

  • 00630414008943 ()
10729780

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Atellica IM 1300 Analyzer
Siemens Healthcare Diagnostics Inc.
11066001
In Commercial Distribution

  • 00630414007960 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
Lithium (Lith) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097535
Not in Commercial Distribution

  • 00630414006789 ()
11097535

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
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