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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 120/2120/2120i® OPTIpoint - 00630414224305

ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10319591
In Commercial Distribution

  • 00630414224305 ()
T03-3682-01

  • Full blood count IVD, calibrator

ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC - 00630414222950

IVD Complete Blood Count Kit CN-FREE
Siemens Healthcare Diagnostics Inc.
10341169
In Commercial Distribution

  • 00630414222950 ()
T01-3626-52

  • Full blood count IVD, kit, cell count

ADVIA 120/2120/2120i® Defoamer - 00630414222943

ADVIA®120/2120/2120i DEFOAMER
Siemens Healthcare Diagnostics Inc.
10312274
In Commercial Distribution

  • 00630414222943 ()
T01-3625-54

  • Full blood count IVD, reagent

IMMULITE 2000 Third Generation TSH - 00630414210841

TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129119
In Commercial Distribution

  • 00630414210841 ()
L2KTS6(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Third Generation TSH - 00630414210834

TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129118
In Commercial Distribution

  • 00630414210834 ()
L2KTS2(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry ISE Urine Standard Set - 00630414210247

ISE Standard Urine - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311904
In Commercial Distribution

  • 00630414210247 ()
B03-4176-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

ADVIA® Chemistry ISE Serum Standard Set - 00630414210230

ISE Standard Serum - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311903
In Commercial Distribution

  • 00630414210230 ()
B03-4175-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

ADVIA® Chemistry APO A1/B Calibrator - 00630414210131

ApolipoproteinA1/B - ADVIA Chem. - CAL - 5x1mL
Siemens Healthcare Diagnostics Inc.
10311898
In Commercial Distribution

  • 00630414210131 ()
  • 00630414003436 ()
B03-4161-01

  • Multiple apolipoprotein IVD, calibrator

ADVIA® Chemistry ISE Buffer - 2 liter - 00630414209968

ISE Buffer - ADVIA Chem. - CONS - 2 Liter
Siemens Healthcare Diagnostics Inc.
10311849
In Commercial Distribution

  • 00630414209968 ()
B01-4171-51

  • pH-adjusted buffer solution IVD

ADVIA Centaur® FSH - 00630414204666

ADVIA Centaur® FSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337964
In Commercial Distribution

  • 00630414204666 ()
  • 00630414010601 ()
118821

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
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