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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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Calibrator B - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206242
In Commercial Distribution

  • 00630414294094 ()
  • 00630414293547 ()
11206242

  • Multiple human hormone IVD, calibrator
Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206241
In Commercial Distribution

  • 00630414294087 ()
  • 00630414293530 ()
11206241

  • Multiple human hormone IVD, calibrator
Dimenison Vista Lipase Flex reagent cartridge
Siemens Healthcare Diagnostics Inc.
11538128
In Commercial Distribution

  • 00630414306254 ()
  • 00630414292762 ()
K3056A

  • Lipase IVD, kit, spectrophotometry
Dimension Lipase (LIP) Flex reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
11538126
In Commercial Distribution

  • 00630414306247 ()
  • 00630414292748 ()
DF56A

  • Lipase IVD, kit, spectrophotometry
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11532568
Not in Commercial Distribution

  • 00630414287270 ()
11532568

  • Lactate IVD, kit, spectrophotometry
Anti-Mullerian Hormone (AMH) - Atellica IM - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205265
In Commercial Distribution

  • 00630414286921 ()
11205265

  • Anti-Mullerian hormone (AMH) IVD, control
Anti-Mullerian Hormone (AMH) - Centaur - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205264
In Commercial Distribution

  • 00630414286914 ()
11205264

  • Anti-Mullerian hormone (AMH) IVD, control
Androstenedione (Andro) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11200558
In Commercial Distribution

  • 00630414285566 ()
11200558

  • Androstenedione IVD, kit, chemiluminescent immunoassay
Androstenedione (Andro) Atellica IM - Master Curve Material 5x1x1.0mL
Siemens Healthcare Diagnostics Inc.
11200557
In Commercial Distribution

  • 00630414285559 ()
11200557

  • Androstenedione IVD, control
Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent
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