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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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ADVIA® Chemistry AMM Ammonia Reagents - 00630414555898

Ammonia - ADVIA Chem. - RGT - 2x138 tests
Siemens Healthcare Diagnostics Inc.
10286035
In Commercial Distribution

  • 00630414555898 ()
4802290

  • Ammonia IVD, kit, spectrophotometry

VERSANT® Sample Preparation 1.0 Reagents (Box 2) - 00630414555553

VERSANT® Sample Preparation 1.0 Reagents (Box 2)
Siemens Healthcare Diagnostics Inc.
10286027
In Commercial Distribution

  • 00630414555553 ()
4801685

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Sample Preparation 1.0 Reagents (Box 1) - 00630414555546

VERSANT® Sample Preparation 1.0 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10286026
In Commercial Distribution

  • 00630414555546 ()
4801677

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® Calibrator A - 00630414555331

Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® ACS:180® Calibrator A - 00630414555324

Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285904
In Commercial Distribution

  • 00630414555324 ()
4800735

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® ACS:180® Calibrator A - 00630414555317

Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10285903
In Commercial Distribution

  • 00630414555317 ()
4800646

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® Systems aHBs2 MCM - 00630414555300

aHBs2 Master Curve Material
Siemens Healthcare Diagnostics Inc.
10285962
In Commercial Distribution

  • 00630414555300 ()
4800387

  • Hepatitis B virus surface total antibody IVD, control

ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat - 00630414555140

HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests)
Siemens Healthcare Diagnostics Inc.
10286032
Not in Commercial Distribution

  • 00630414555140 ()
4795367

  • Glycated haemoglobin (HbA1c) IVD, reagent

ADVIA Centaur® T3 - 00630414554631

T3 Total (Ref) - CENTAUR - RGT - 400 tests
Siemens Healthcare Diagnostics Inc.
10285734
In Commercial Distribution

  • 00630414554631 ()
  • 00630414010700 ()
4779779

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® T3 - 00630414554624

T3 Total - CENTAUR - RGT - 80 tests
Siemens Healthcare Diagnostics Inc.
10285733
In Commercial Distribution

  • 00630414554624 ()
4779671

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
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