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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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Atellica IM CA 15-3 - 00630414293509

CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206238
In Commercial Distribution

  • 00630414294063 ()
  • 00630414293509 ()
11206238

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 125II - 00630414293493

CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206266
In Commercial Distribution

  • 00630414294278 ()
  • 00630414293493 ()
11206266

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 19-9 - 00630414598178

CA 19-9 - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995490
In Commercial Distribution

  • 00630414598178 ()
10995490

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 19-9 - 00630414598161

CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995489
In Commercial Distribution

  • 00630414598161 ()
10995489

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 15-3 - 00630414598130

CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995486
In Commercial Distribution

  • 00630414598130 ()
  • 00630414007397 ()
10995486

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 15-3 - 00630414598123

CA 15-3 Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995485
In Commercial Distribution

  • 00630414598123 ()
10995485

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 125II - 00630414598093

CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995482
In Commercial Distribution

  • 00630414598093 ()
  • 00630414007380 ()
10995482

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Atellica IM CA 125II - 00630414598086

CA 125II Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995481
In Commercial Distribution

  • 00630414598086 ()
10995481

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® CA 19-9 DIL - 00630414577135

CA 19-9 bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10491974
In Commercial Distribution

  • 00630414577135 ()
10491974

  • Buffered sample diluent IVD

ADVIA Centaur® CA 19-9™ - 00630414574257

CA 19-9 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10491379
In Commercial Distribution

  • 00630414574257 ()
10491379

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
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