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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A1C Reagent Kit
Siemens Healthcare Diagnostics Inc.
10720883
In Commercial Distribution

  • 00630414006659 ()
DF105B

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Creatine Kinase Liquid (CK_L) Atellica CH - RGT 664T
Siemens Healthcare Diagnostics Inc.
11097640
In Commercial Distribution

  • 00630414006642 ()
11097640

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
ADVIA A1c_E Pretreatment Solution, 1L
Siemens Healthcare Diagnostics Inc.
10721048
In Commercial Distribution

  • 00630414002880 ()
10721048

  • Glycated haemoglobin (HbA1c) IVD, reagent
ADVIA A1c_E Reagent (Large Kit), 1200 tests
Siemens Healthcare Diagnostics Inc.
10720858
In Commercial Distribution

  • 00630414002866 ()
10720858

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719666
In Commercial Distribution

  • 00630414000497 ()
10719666

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Digoxin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311623
In Commercial Distribution

  • 00630414126296 ()
672426000

  • Digoxin therapeutic drug monitoring IVD, control
Free T3 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311622
In Commercial Distribution

  • 00630414126289 ()
672425000

  • Free triiodothyronine (FT3) IVD, control
IgE Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311621
In Commercial Distribution

  • 00630414126265 ()
672423000

  • Total immunoglobulin E (IgE total) IVD, control
TSH Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311620
In Commercial Distribution

  • 00630414126258 ()
672422000

  • Thyroid stimulating hormone (TSH) IVD, control
T4 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311619
In Commercial Distribution

  • 00630414126234 ()
672420000

  • Total thyroxine (TT4) IVD, control
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