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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Active-B12 (AB12) Atellica IM - Master Curve Material Kit 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10733003
In Commercial Distribution

  • 00630414245744 ()
10733003

  • Holotranscobalamin (holoTC) IVD, control
Active-B12 (AB12) QC Kit Atellica IM - CLT 2 x 1 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733002
In Commercial Distribution

  • 00630414245737 ()
10733002

  • Holotranscobalamin (holoTC) IVD, control
Active-B12 (AB12) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733001
In Commercial Distribution

  • 00630414245720 ()
10733001

  • Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay
anti-CCP IgG (aCCP) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10733000
In Commercial Distribution

  • 00630414245683 ()
10733000

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10732999
In Commercial Distribution

  • 00630414245676 ()
10732999

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
anti-CCP IgG (aCCP) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10732998
In Commercial Distribution

  • 00630414245669 ()
10732998

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
Vista T4/TU CAL
Siemens Healthcare Diagnostics Inc.
11319105
In Commercial Distribution

  • 00630414240268 ()
KC165

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11202258
In Commercial Distribution

  • 00630414238807 ()
11202258

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202257
In Commercial Distribution

  • 00630414238791 ()
11202257

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Procalcitonin (PCT) DM EXL LOCI BRAHMS - Cal Kit
Siemens Healthcare Diagnostics Inc.
11354448
In Commercial Distribution

  • 00630414295039 ()
  • 00630414238708 ()
RC648

  • Procalcitonin (PCT) IVD, calibrator
Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Siemens Healthcare Diagnostics Inc.
11354447
In Commercial Distribution

  • 00630414298214 ()
  • 00630414238692 ()
RF648

  • Procalcitonin (PCT) IVD, reagent
Amylase_2 (AMY_2) Atellica CH - RGT 1050T
Siemens Healthcare Diagnostics Inc.
11097649
In Commercial Distribution

  • 00630414238357 ()
11097649

  • Total amylase IVD, kit, spectrophotometry
Tacrolimus (TACR) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097542
In Commercial Distribution

  • 00630414238340 ()
11097542

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Siemens Healthcare Diagnostics Inc.
10736583
In Commercial Distribution

  • 00630414238142 ()
10736583

  • Medical equipment clinical data interfacing software
Cystatin C_2 (CYSC_2) Calibrators Atellica CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11097648
In Commercial Distribution

  • 00630414238104 ()
11097648

  • Cystatin C IVD, calibrator
Oxycodone (OXY) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097541
In Commercial Distribution

  • 00630414238098 ()
11097541

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
ADVIA 2120i Refurbished System, Without Autosampler
Siemens Healthcare Diagnostics Inc.
11314046
In Commercial Distribution

  • 00630414237909 ()
11314046

  • Haematological cell analyser IVD
ADVIA 2120i Refurbished System, Dual Aspirate
Siemens Healthcare Diagnostics Inc.
11314045
In Commercial Distribution

  • 00630414237886 ()
11314045

  • Haematological cell analyser IVD
ADVIA 2120i Refurbished System, Single Aspirate
Siemens Healthcare Diagnostics Inc.
11314044
In Commercial Distribution

  • 00630414237879 ()
11314044

  • Haematological cell analyser IVD
Atellica IM Multi-Diluent 15
Siemens Healthcare Diagnostics Inc.
11200798
In Commercial Distribution

  • 00630414246826 ()
  • 00630414237701 ()
11200798

  • Buffered sample diluent IVD
Cystatin C_2 (CYSC_2) Atellica CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097647
In Commercial Distribution

  • 00630414236919 ()
11097647

  • Cystatin C IVD, kit, nephelometry/turbidimetry
ADVIA Centaur® Testosterone (TSTO) Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11201912
Not in Commercial Distribution

  • 00630414235271 ()
11201912

  • Total testosterone IVD, kit, chemiluminescent immunoassay
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
No Description
Siemens Healthcare Diagnostics Inc.
10995083
In Commercial Distribution

  • 00630414010472 ()
10995083

  • Interleukin-6 (IL-6) IVD, control
ADVIA Centaur ® IL-6 100T Kit
Siemens Healthcare Diagnostics Inc.
10995080
In Commercial Distribution

  • 00630414010434 ()
10995080

  • Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay
Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10995099
In Commercial Distribution

  • 00630414010403 ()
10995099

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10995098
In Commercial Distribution

  • 00630414010397 ()
10995098

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) - ADVIA Centaur - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995096
In Commercial Distribution

  • 00630414010380 ()
10995096

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
Calcitonin (CALCT) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995094
In Commercial Distribution

  • 00630414010373 ()
10995094

  • Calcitonin IVD, control
Aspartate Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097639
In Commercial Distribution

  • 00630414009063 ()
11097639

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097638
In Commercial Distribution

  • 00630414009056 ()
11097638

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
6 vials of 1 calibrator level
Siemens Healthcare Diagnostics Inc.
10916059
In Commercial Distribution

  • 00630414008981 ()
10916059

  • Total creatine kinase (CK) IVD, calibrator
Enzyme 2 Calibrator - ADVIA Chemistry (ENZ 2 CAL)
Siemens Healthcare Diagnostics Inc.
10916058
In Commercial Distribution

  • 00630414008974 ()
10916058

  • Multiple clinical chemistry enzyme IVD, calibrator
Enzyme 1 Calibrator - ADVIA Chemistry (ENZ 1 CAL)
Siemens Healthcare Diagnostics Inc.
10916057
In Commercial Distribution

  • 00630414008967 ()
10916057

  • Multiple clinical chemistry enzyme IVD, calibrator
ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc
Siemens Healthcare Diagnostics Inc.
10729782
In Commercial Distribution

  • 00630414306193 ()
  • 00630414008950 ()
10729782

  • Multiple clinical chemistry enzyme IVD, reagent
4 wedges per reagent , 2 reagent, 1100 test per carton
Siemens Healthcare Diagnostics Inc.
10729780
In Commercial Distribution

  • 00630414008943 ()
10729780

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Atellica IM 1300 Analyzer
Siemens Healthcare Diagnostics Inc.
11066001
In Commercial Distribution

  • 00630414007960 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
Lithium (Lith) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097535
Not in Commercial Distribution

  • 00630414006789 ()
11097535

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
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