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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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FastPack® Pro System - 00816467020372

RoHS Compliant 7-chamber FastPack System
QUALIGEN INC.
Pro System
In Commercial Distribution

  • 00816467020372 ()
08000067, 08000067-R, 08000067-X

  • Chemiluminescent immunoassay analyser IVD

FastPack® IP System - 00816467020334

RoHS Compliant FastPack System
QUALIGEN INC.
IP System
In Commercial Distribution

  • 00816467020334 ()
08000043-C, 08000043-CR

  • Chemiluminescent immunoassay analyser IVD

FastPack® IP System - 00816467020006

No Description
QUALIGEN INC.
IP System
In Commercial Distribution

  • 00816467020006 ()
08000043, 08000043-R, 08000043-X

  • Chemiluminescent immunoassay analyser IVD

ViraChip Scanner - EVIRUVCSCA1

ViraChip Scanner
Viramed Biotech AG
V-UVCSCA
In Commercial Distribution

  • EVIRUVCSCA1 ()
V-UVCSCA

  • Microplate digital imaging scanner IVD

ViraChip Reader - EVIRUVCCAM1

ViraChip Reader
Viramed Biotech AG
V-UVCCAM
In Commercial Distribution

  • EVIRUVCCAM1 ()
V-UVCCAM

  • Microplate digital imaging scanner IVD

ADVIA Centaur® CP Instrument - 00630414593302

ADVIA® CENTAUR® CP Refurbished Instrument
Siemens Healthcare Diagnostics Inc.
10476243
In Commercial Distribution

  • 00630414593302 ()
086-A002R01

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® XP Analyzer - 00630414585475

ADVIA® CENTAUR® XP Refurbished Instrument
Siemens Healthcare Diagnostics Inc.
10471899
In Commercial Distribution

  • 00630414585475 ()
078-A011R03

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® XP Analyzer - 00630414573564

ADVIA® CENTAUR® XP Instrument
Siemens Healthcare Diagnostics Inc.
10364455
In Commercial Distribution

  • 00630414573564 ()
078-A011-03

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® CP Immunoassay System - 00630414523286

ADVIA® CENTAUR® CP Instrument
Siemens Healthcare Diagnostics Inc.
10309710
In Commercial Distribution

  • 00630414523286 ()
086-A002-01

  • Chemiluminescent immunoassay analyser IVD

ADVIA Centaur® XPT Analyzer - 00630414596914

ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
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