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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 Centaur® aCCP IgG MCM - 00630414592305

Anti-CCP IgG (aCCP) MCM
Siemens Healthcare Diagnostics Inc.
10699140
In Commercial Distribution

  • 00630414592305 ()
10699140

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

ADVIA Centaur® aHBs2 - 00630414591407

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10698706
In Commercial Distribution

  • 00630414591407 ()
10698706

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBeAg - 00630414591315

Hepatitis B e Antigen (HBeAg) Assay Kit (1-pack) 50T
Siemens Healthcare Diagnostics Inc.
10698639
In Commercial Distribution

  • 00630414591315 ()
10698639

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® PTH - 00630414591278

Intact parathyroid hormone Master Curve Material (iPTH MCM) Set - 7x1 mL - 7 Levels.
Siemens Healthcare Diagnostics Inc.
10698597
In Commercial Distribution

  • 00630414591278 ()
10698597

  • Parathyroid hormone (PTH) IVD, control

ADVIA Centaur® TSTII - 00630414591155

Testosterone II (TSTII) - ADVIA Centaur® - RGT (REF) – 500T
Siemens Healthcare Diagnostics Inc.
10696864
In Commercial Distribution

  • 00630414591155 ()
10696864

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® TST II - 00630414591148

Testosterone II - RGT - CENTAUR - 500 tests
Siemens Healthcare Diagnostics Inc.
10696863
In Commercial Distribution

  • 00630414591148 ()
10696863

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® TST II - 00630414591131

Testosterone II - RGT -100 Tests
Siemens Healthcare Diagnostics Inc.
10696862
In Commercial Distribution

  • 00630414591131 ()
10696862

  • Total testosterone IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® eE2 - 00630414591056

Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10697757
In Commercial Distribution

  • 00630414591056 ()
10697757

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Calibrator 30 - 00630414591049

ADVIA Centaur® Calibrator 30 (2-pack)
Siemens Healthcare Diagnostics Inc.
10697756
In Commercial Distribution

  • 00630414591049 ()
10697756

  • Multiple steroid hormone IVD, calibrator

Clinitek Novus® Cal 1-4 kit - 00630414590950

Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator
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