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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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Titin ELISA & CLIA Analyzer - 00816870023991

No Description
MONOBIND, INC.
IN015-EC
In Commercial Distribution

  • 00816870023991 ()
IN015-EC

  • Multi-modality clinical specimen analysis system IVD

ProTube - 07640172343012

ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343012 ()


  • Specimen information management system IVD

ProTube - 07640172343005

The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343005 ()


  • Specimen information management system IVD

cobas pro B-Gate update Kit - 07613336164846

No Description
Roche Diagnostics GmbH
08763640001
In Commercial Distribution

  • 07613336164846 ()
08763640001

  • Multi-modality clinical specimen analysis system IVD

cobas c 503 analytical unit - 07613336158784

No Description
Roche Diagnostics GmbH
08463662001
In Commercial Distribution

  • 07613336158784 ()
08463662001

  • Multi-modality clinical specimen analysis system IVD

Bolt - B35000500R0

Bolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00500R
In Commercial Distribution

  • B35000500R0 ()
00500R

  • Enzyme immunoassay (EIA) analyser IVD

Bolt - B350005000

Bolt EIA
Gold Standard Diagnostics Corporation
00500
In Commercial Distribution

  • B350005000 ()
00500

  • Enzyme immunoassay (EIA) analyser IVD

ThunderBolt EIA - B35000300R0

ThunderBolt EIA (refurbished)
Gold Standard Diagnostics Corporation
00300R
In Commercial Distribution

  • B35000300R0 ()
00300R

  • Enzyme immunoassay (EIA) analyser IVD

ThunderBolt EIA - B350003000

No Description
Gold Standard Diagnostics Corporation
00300
In Commercial Distribution

  • B350003000 ()
00300

  • Enzyme immunoassay (EIA) analyser IVD

Autoplex G2 ELISA + CLIA Analyzer - 00816870020082

No Description
MONOBIND, INC.
IN006-2
In Commercial Distribution

  • 00816870020082 ()
IN006-2

  • Multi-modality clinical specimen analysis system IVD
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