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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TSH3-UL - Atellica IM - RGT 2750T
Siemens Healthcare Diagnostics Inc.
11206262
In Commercial Distribution

  • 00630414293875 ()
11206262

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206312
In Commercial Distribution

  • 00630414294285 ()
  • 00630414293868 ()
11206312

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
DHEAS - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206311
In Commercial Distribution

  • 00630414293844 ()
11206311

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Vitamin B12 (VB12) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206264
In Commercial Distribution

  • 00630414294261 ()
  • 00630414293820 ()
11206264

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Testoterone II (TSTII) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206263
In Commercial Distribution

  • 00630414293813 ()
11206263

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TnI-Ultra - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206219
In Commercial Distribution

  • 00630414293790 ()
11206219

  • Troponin I IVD, kit, chemiluminescent immunoassay
High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206269
In Commercial Distribution

  • 00630414293783 ()
11206269

  • Troponin I IVD, kit, chemiluminescent immunoassay
Follicle Stimulating Hormone (FSH) - Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
11206253
In Commercial Distribution

  • 00630414294179 ()
  • 00630414293660 ()
11206253

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Folic Acid (Fol) - Atellica IM - RGT 700T
Siemens Healthcare Diagnostics Inc.
11206252
In Commercial Distribution

  • 00630414293653 ()
11206252

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Ferritin (Fer) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
11206251
In Commercial Distribution

  • 00630414294162 ()
  • 00630414293646 ()
11206251

  • Ferritin IVD, kit, chemiluminescent immunoassay
Estradiol (eE2) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206250
In Commercial Distribution

  • 00630414293639 ()
11206250

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11206197
In Commercial Distribution

  • 00630414293622 ()
11206197

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
C-Peptide (CpS) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206249
In Commercial Distribution

  • 00630414293615 ()
11206249

  • C-peptide IVD, kit, chemiluminescent immunoassay
Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206248
In Commercial Distribution

  • 00630414294155 ()
  • 00630414293608 ()
11206248

  • Total cortisol IVD, kit, chemiluminescent immunoassay
CKMB - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206247
In Commercial Distribution

  • 00630414294148 ()
  • 00630414293592 ()
11206247

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206245
In Commercial Distribution

  • 00630414294124 ()
  • 00630414293578 ()
11206245

  • Multiple steroid hormone IVD, calibrator
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 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206266
In Commercial Distribution

  • 00630414294278 ()
  • 00630414293493 ()
11206266

  • Cancer antigen 125 (CA125) 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
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
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
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™ 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 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
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