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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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VERSANT HCV Control 2.0 Kit (LiPA) - 00630414000510

VERSANT HCV Control 2.0 Kit
Siemens Healthcare Diagnostics Inc.
10719668
In Commercial Distribution

  • 00630414000510 ()
10719668

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

VERSANT HCV 2.0 LiPA - 00630414000503

VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
Siemens Healthcare Diagnostics Inc.
10719667
In Commercial Distribution

  • 00630414000503 ()
10719667

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

VERSANT HCV 2.0 LiPA - 00630414000497

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)

RAPIDComm® Data Management System - 00630414000466

The RAPIDComm® program manages the process of sending and receiving data from devices and hospital systems located anywhere in your network.
Siemens Healthcare Diagnostics Inc.
11065134
In Commercial Distribution

  • 00630414000466 ()
11065134

  • Medical equipment clinical data interfacing software

ADVIA Autoslide® Slide Maker Stainer - 00630414000220

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282178
In Commercial Distribution

  • 00630414000220 ()
085-A002-03

  • Microscope slide maker/stainer IVD

ADVIA® Chemistry MYO Myoglobin Reagents - 00630414000190

Myoglobin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361939
Not in Commercial Distribution

  • 00630414000190 ()
4862455

  • Myoglobin IVD, kit, nephelometry/turbidimetry

ADVIA Centaur® HAV IgM QC - 00630414480008

HAV IgM - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309084
In Commercial Distribution

  • 00630414480008 ()
5004800

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

ADVIA Centaur® HAV IgM - 00630414479996

HAV IgM Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309083
In Commercial Distribution

  • 00630414479996 ()
5004126

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry ToxAmmonia Cal - 00630414479286

Alcohol / Ammonia Kit - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10309217
In Commercial Distribution

  • 00630414479286 ()
  • 00630414003047 ()
6549444

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry - 00630414479095

Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry for use with Clintek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10315660
In Commercial Distribution

  • 00630414479095 ()
5085

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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