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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® Systems iPTH Calibrator - 00630414472553

Intact PTH - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10309042
In Commercial Distribution

  • 00630414472553 ()
2698011

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA® 120/2120/2120i TESTpoint CSF Control Kit - 00630414472539

ADVIA®120/2120/2120i TESTpoint™ CSF Control Kit
Siemens Healthcare Diagnostics Inc.
10314243
In Commercial Distribution

  • 00630414472539 ()
T03-4485-01

  • Full blood count IVD, control

VERSANT® HCV RNA 3.0 ASSAY bDNA - 00630414472393

HCV RNA 3.0 Assay (bDNA) US IVD (Box 2)
Siemens Healthcare Diagnostics Inc.
10333501
Not in Commercial Distribution

  • 00630414472393 ()
2554338

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

VERSANT® HCV RNA 3.0 ASSAY bDNA - 00630414472386

HCV RNA 3.0 Assay (bDNA) US IVD (Box 1)
Siemens Healthcare Diagnostics Inc.
10333499
Not in Commercial Distribution

  • 00630414472386 ()
2553870

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ADVIA Centaur® aHBs - 00630414471914

Anti-HBs (aHBs) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10309021
Not in Commercial Distribution

  • 00630414471914 ()
1463789

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

ADVIA Centaur® Systems aHBs QC - 00630414471860

Anti-HBs (aHBs) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309020
Not in Commercial Distribution

  • 00630414471860 ()
1453546

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® H2n - 00630414471235

HER-2/neu - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10308994
In Commercial Distribution

  • 00630414471235 ()
915031

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® H2n Calibrator - 00630414471228

HER-2/Neu - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308993
In Commercial Distribution

  • 00630414471228 ()
913551

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator

ADVIA Centaur® H2n QC - 00630414471211

HER-2/Neu - CENTAUR - CONS - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308992
In Commercial Distribution

  • 00630414471211 ()
913276

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

RAPIDChem® 744 - 00630414471112

The Rapidchem® 744 analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), and Cl- (chloride) or Lithium (Li+) in serum, plasma, whole blood and urine (not applicable for Lithium) samples.
Siemens Healthcare Diagnostics Inc.
10324039
In Commercial Distribution

  • 00630414471112 ()
6254738

  • Ion-selective analyser IVD, semi-automated
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