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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® 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® 2000 Systems BMG Beta-2 Microglobulin - 00630414961071

b2 Microglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380992
In Commercial Distribution

  • 00630414961071 ()
L2KBM2

  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems AF AFP - 00630414961040

AF AFP Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381184
In Commercial Distribution

  • 00630414961040 ()
L2KAP6

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems AF AFP - 00630414961033

AF AFP Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381187
In Commercial Distribution

  • 00630414961033 ()
L2KAP2

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems AND Androstenedione - 00630414961026

Androstenedione - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381188
In Commercial Distribution

  • 00630414961026 ()
L2KAO2

  • Androstenedione IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems ACT ACTH - 00630414960999

ACTH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381468
In Commercial Distribution

  • 00630414960999 ()
L2KAC2

  • Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay

IMMULITE®1000 System ID4 ID4 Sample Diluent - 00630414960975

ID4 Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381266
In Commercial Distribution

  • 00630414960975 ()
  • 00630414601748 ()
L1KMCW1

  • Buffered sample diluent IVD

IMMULITE® 1000 System ID1 IgG/IgM Sample Diluent - 00630414960951

Torch IGG/IGM - IMMULITE - CONS - 2 wedges
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387608
In Commercial Distribution

  • 00630414960951 ()
L1KIGW1

  • Buffered sample diluent IVD

IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent - 00630414960944

Infectious Disease Diluent - IMMULITE - CAL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385353
In Commercial Distribution

  • 00630414960944 ()
L1KIDW1

  • Buffered sample diluent IVD

IMMULITE® 1000 System SD2 DIL HCG Sample Diluent - 00630414960920

HCG Diluent Module - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385351
In Commercial Distribution

  • 00630414960920 ()
L1KCGW1

  • Buffered sample diluent IVD
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