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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Dimension Vista ECREA CAL
Siemens Healthcare Diagnostics Inc.
11349584
In Commercial Distribution

  • 00630414235103 ()
KC270A

  • Creatinine IVD, calibrator
Dimension Vista CHEM 1 CAL
Siemens Healthcare Diagnostics Inc.
11349583
In Commercial Distribution

  • 00630414235097 ()
KC110C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11201773
In Commercial Distribution

  • 00630414234489 ()
11201773

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11201772
In Commercial Distribution

  • 00630414234472 ()
11201772

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Syva Emit II Plus 6-Acetylmorphine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10730975
In Commercial Distribution

  • 00630414229591 ()
9R029UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
Atellica CI Rack Handler
Siemens Healthcare Diagnostics Inc.
10947348
In Commercial Distribution

  • 00630414229560 ()
10947348

  • Specimen processing instrument IVD
Atellica CI Analyzer
Siemens Healthcare Diagnostics Inc.
10947347
In Commercial Distribution

  • 00630414229553 ()
10947347

  • Multiple clinical chemistry analyser IVD, laboratory
Setpoint CO2 - ADVIA Chem. - CAL - 2x21mL
Siemens Healthcare Diagnostics Inc.
10326423
In Commercial Distribution

  • 00630414227887 ()
  • 00630414003603 ()
T23-1291-52

  • Carbon dioxide (CO2) IVD, calibrator
AMH - Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998432
In Commercial Distribution

  • 00630414225692 ()
10998432

  • Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay
AMH - Centaur - Master Curve Material Kit 4 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998430
In Commercial Distribution

  • 00630414225685 ()
10998430

  • Anti-Mullerian hormone (AMH) IVD, control
Ancillary Probe Wash - Atellica™ IM - CONS 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10998580
In Commercial Distribution

  • 00630414225081 ()
  • 00842768027390 ()
10998580

  • Buffered wash solution IVD
ADVIA Chemistry Cystatin C_2 Calibrator
Siemens Healthcare Diagnostics Inc.
10734510
In Commercial Distribution

  • 00630414224923 ()
10734510

  • Cystatin C IVD, calibrator
ADVIA Chemistry Cystatin C_2 Assay
Siemens Healthcare Diagnostics Inc.
10734503
In Commercial Distribution

  • 00630414224916 ()
10734503

  • Cystatin C IVD, kit, nephelometry/turbidimetry
ADVIA®120/2120/2120i TESTpoint™ Retic High Control
Siemens Healthcare Diagnostics Inc.
10312295
In Commercial Distribution

  • 00630414224442 ()
T03-3691-54

  • Reticulocyte count IVD, control
ADVIA®120/2120/2120i TESTpoint™ Retic Control Low
Siemens Healthcare Diagnostics Inc.
10312293
In Commercial Distribution

  • 00630414224428 ()
T03-3690-54

  • Reticulocyte count IVD, control
ADVIA®120/2120/2120i TESTpoint™ High Control
Siemens Healthcare Diagnostics Inc.
10312291
In Commercial Distribution

  • 00630414224404 ()
T03-3688-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i Testpoint™ Norm Control
Siemens Healthcare Diagnostics Inc.
10312289
In Commercial Distribution

  • 00630414224381 ()
T03-3687-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i Testpoint™ Low Control
Siemens Healthcare Diagnostics Inc.
10312287
In Commercial Distribution

  • 00630414224367 ()
T03-3686-54

  • Full blood count IVD, control
ADVIA®120/2120/2120i SETpoint™
Siemens Healthcare Diagnostics Inc.
10312285
In Commercial Distribution

  • 00630414224343 ()
T03-3685-52

  • Full blood count IVD, calibrator
ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10312283
In Commercial Distribution

  • 00630414224329 ()
T03-3682-54

  • Full blood count IVD, calibrator
ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10319591
In Commercial Distribution

  • 00630414224305 ()
T03-3682-01

  • Full blood count IVD, calibrator
Setpoint - ADVIA Chem. - CAL - 12x3mL
Siemens Healthcare Diagnostics Inc.
10312279
In Commercial Distribution

  • 00630414223414 ()
  • 00630414003474 ()
T03-1291-62

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
ADVIA®120/2120/2120i SHEATH/RINSE
Siemens Healthcare Diagnostics Inc.
10316869
In Commercial Distribution

  • 00630414223032 ()
T01-3664-01

  • Wash/cleaning solution IVD, automated/semi-automated system
IVD Complete Blood Count Kit CN-FREE
Siemens Healthcare Diagnostics Inc.
10341169
In Commercial Distribution

  • 00630414222950 ()
T01-3626-52

  • Full blood count IVD, kit, cell count
ADVIA®120/2120/2120i DEFOAMER
Siemens Healthcare Diagnostics Inc.
10312274
In Commercial Distribution

  • 00630414222943 ()
T01-3625-54

  • Full blood count IVD, reagent
ADVIA®120/2120/2120i SHEATH/RINSE
Siemens Healthcare Diagnostics Inc.
10312272
In Commercial Distribution

  • 00630414222929 ()
T01-3623-01

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA®120/2120/2120i autoRETIC
Siemens Healthcare Diagnostics Inc.
10312271
In Commercial Distribution

  • 00630414222912 ()
T01-3622-54

  • Reticulocyte count IVD, kit, cell count
ADVIA®120/2120/2120i autoRETIC
Siemens Healthcare Diagnostics Inc.
10330709
In Commercial Distribution

  • 00630414222905 ()
T01-3622-51

  • Reticulocyte count IVD, kit, cell count
ADVIA®120/2120/2120i DIFF TIMEPAC®
Siemens Healthcare Diagnostics Inc.
10312270
In Commercial Distribution

  • 00630414222899 ()
T01-3621-52

  • White blood cell count IVD, kit, cell count
ADVIA®120/2120/2120i CBCTIMEPAC®
Siemens Healthcare Diagnostics Inc.
10312269
In Commercial Distribution

  • 00630414222882 ()
T01-3620-52

  • Full blood count IVD, kit, cell count
Pipette tip
Siemens Healthcare Diagnostics Inc.
10309547
In Commercial Distribution

  • 00630414222608 ()
078-K139-01

  • Pipette tip IVD
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
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