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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Progesterone (PRGE) - Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206257
In Commercial Distribution

  • 00630414294216 ()
  • 00630414293714 ()
11206257

  • Progesterone IVD, kit, chemiluminescent immunoassay
Luteinizing Hormone (LH) - Atellica IM - RGT - 550T
Siemens Healthcare Diagnostics Inc.
11206256
In Commercial Distribution

  • 00630414294209 ()
  • 00630414293707 ()
11206256

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206255
In Commercial Distribution

  • 00630414294193 ()
  • 00630414293684 ()
11206255

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Calibrator D - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206244
In Commercial Distribution

  • 00630414294117 ()
  • 00630414293561 ()
11206244

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
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 30 - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206240
In Commercial Distribution

  • 00630414294070 ()
  • 00630414293523 ()
11206240

  • Multiple steroid hormone IVD, calibrator
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
CA 15-3 Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206238
In Commercial Distribution

  • 00630414294063 ()
  • 00630414293509 ()
11206238

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
BR CA27-29 - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206236
In Commercial Distribution

  • 00630414294049 ()
  • 00630414293479 ()
11206236

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
Dimenison Vista Lipase Flex reagent cartridge
Siemens Healthcare Diagnostics Inc.
11538128
In Commercial Distribution

  • 00630414306254 ()
  • 00630414292762 ()
K3056A

  • Lipase IVD, kit, spectrophotometry
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
Haptoglobin (Hapt) Atellica™ CH - RGT 150T
Siemens Healthcare Diagnostics Inc.
11097643
Not in Commercial Distribution

  • 00630414210827 ()
11097643

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
ISE Standard Urine - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311904
In Commercial Distribution

  • 00630414210247 ()
B03-4176-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
ISE Standard Serum - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311903
In Commercial Distribution

  • 00630414210230 ()
B03-4175-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
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