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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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cobas e 801 Immunoassay analyzer - 07613336158456

No Description
Roche Diagnostics GmbH
08454345001
In Commercial Distribution

  • 07613336158456 ()
08454345001

  • Chemiluminescent immunoassay analyser IVD

cobas e 402 analytical unit - 07613336220139

No Description
Roche Diagnostics GmbH
09793020001
In Commercial Distribution

  • 07613336220139 ()
09793020001

  • Chemiluminescent immunoassay analyser IVD

FastPack® IP System - 00816467020402

No Description
QUALIGEN INC.
IP System
In Commercial Distribution

  • 00816467020402 ()
08000043-X2

  • Chemiluminescent immunoassay analyser IVD

FastPack® IP System - 00816467020396

No Description
QUALIGEN INC.
IP System
In Commercial Distribution

  • 00816467020396 ()
08000043-A, 08000043-AR

  • Chemiluminescent immunoassay analyser IVD

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

Alinity - 00380740137410

Alinity ci-series System Control Module
ABBOTT LABORATORIES
03R7001
In Commercial Distribution

  • 00380740137410 ()
03R7001

  • Chemiluminescent immunoassay analyser IVD

Alinity - 00380740137366

Alinity i Processing Module
ABBOTT LABORATORIES
03R6501
In Commercial Distribution

  • 00380740137366 ()
03R6501

  • Chemiluminescent immunoassay analyser IVD

ARCHITECT - 00380740103156

ARCHITECT i1000SR REFURBISHED PROCESSING MODULE
ABBOTT LABORATORIES
1L86-98
In Commercial Distribution

  • 00380740103156 ()
01L8698

  • Chemiluminescent immunoassay analyser IVD
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