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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 Type Device Class Implantable

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ORTHO - 10758750005499

OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520563939

BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520563922

U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563922 ()

  • 1 Each
12001443

  • Laboratory instrument/analyser application software IVD

BioPlex® 2200 - 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520178904

U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5
BIO-RAD LABORATORIES, INC.
SW4.3_v5
In Commercial Distribution

  • 03610520178904 ()

  • 1 Each
12003844

  • Laboratory instrument/analyser application software IVD

STA Coag Expert® - 03607450871111

No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450871111 ()
87111

  • Laboratory instrument/analyser application software IVD

Coag.One server license - 03607450867657

No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450867657 ()
86765

  • Laboratory instrument/analyser application software IVD

Coag.One server license - 03607450000047

No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000047 ()
86765

  • Laboratory instrument/analyser application software IVD

STA Coag Expert® - 03607450000030

No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000030 ()
87111

  • Laboratory instrument/analyser application software IVD

Alinity c ACE Assay File - 08058056685445

The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD
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