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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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IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) - 00630414964331

CA 125 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380969
In Commercial Distribution

  • 00630414964331 ()
LKOP1

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

IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) - 00630414963655

CA 15-3 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380948
In Commercial Distribution

  • 00630414963655 ()
LKBR1

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

IMMULITE® 2000 Systems OV OM-MA (CA125) - 00630414961798

CA 125 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380972
In Commercial Distribution

  • 00630414961798 ()
L2KOP2

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

IMMULITE® 2000 Systems BRM BR-MA (CA15-3) - 00630414961088

CA 15-3 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380983
In Commercial Distribution

  • 00630414961088 ()
L2KBR2

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

IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA Sample Diluent - 00630414953601

CA 15-3 Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387018
In Commercial Distribution

  • 00630414953601 ()
LBRZ

  • Buffered sample diluent IVD

ADVIA Centaur® CA 15-3® - 00630414461328

CA 15-3 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10312831
In Commercial Distribution

  • 00630414461328 ()
  • 00630414003481 ()
128535

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

ADVIA Centaur® CA 15-3® - 00630414461311

CA 15-3 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10327620
In Commercial Distribution

  • 00630414461311 ()
128534

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

ADVIA Centaur® CA 125 II - 00630414461304

CA 125 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10315696
In Commercial Distribution

  • 00630414461304 ()
  • 00630414003504 ()
128533

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

ADVIA Centaur® CA 125II - 00630414461298

CA 125 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310443
In Commercial Distribution

  • 00630414461298 ()
128532

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

Atellica IM CA 19-9 - 00630414293516

CA 19-9 Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206239
In Commercial Distribution

  • 00630414293516 ()
11206239

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