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 Class Implantable

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Laboratory analyser cuvette, IVD
Siemens Healthcare Diagnostics Inc.
10309546
In Commercial Distribution

  • 00630414221588 ()
078-K138-01

  • Laboratory analyser cuvette IVD, single-use
No Description
Siemens Healthcare Diagnostics Inc.
10309545
In Commercial Distribution

  • 00630414221571 ()
078-K137-01

  • Assay container IVD, single-use
Calcium_2 (CA_2) Atellica CH - RGT 8200T
Siemens Healthcare Diagnostics Inc.
11097644
In Commercial Distribution

  • 00630414220697 ()
  • 00630414246413 ()
11097644

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Lidocaine (LIDO) Atellica CH - RGT 200T
Siemens Healthcare Diagnostics Inc.
11097539
In Commercial Distribution

  • 00630414220680 ()
11097539

  • Lidocaine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Procainamide (PROC) Atellica CH - RGT 200T
Siemens Healthcare Diagnostics Inc.
11097538
In Commercial Distribution

  • 00630414220673 ()
11097538

  • Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
N-Acetylprocainamide (NAPA) Atellica CH - RGT 200T
Siemens Healthcare Diagnostics Inc.
11097537
In Commercial Distribution

  • 00630414220659 ()
11097537

  • N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Enzymatic Hemoglobin A1c (A1c_E) Calibrator Atellica CH - CAL 1 x 5.0 mL, 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
11099338
In Commercial Distribution

  • 00630414220512 ()
11099338

  • Glycated haemoglobin (HbA1c) IVD, calibrator
Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T
Siemens Healthcare Diagnostics Inc.
11097536
In Commercial Distribution

  • 00630414220505 ()
11097536

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
Multidil 15 ReadyPack (2PK) - CENTAUR - 2x25 mL
Siemens Healthcare Diagnostics Inc.
11200097
In Commercial Distribution

  • 00630414211015 ()
  • 00630414223513 ()
11200097

  • Buffered sample diluent IVD
Haptoglobin (Hapt) Atellica™ CH - RGT 150T
Siemens Healthcare Diagnostics Inc.
11097643
Not in Commercial Distribution

  • 00630414210827 ()
11097643

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
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