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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DHEA-S Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387020
In Commercial Distribution

  • 00630414953694 ()
LDSZ

  • Buffered sample diluent IVD
TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385395
In Commercial Distribution

  • 00630414953311 ()
LTGCM

  • Thyroid stimulating hormone (TSH) IVD, control
PTH - IMMULITE - CTL - 6x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385354
In Commercial Distribution

  • 00630414953236 ()
LPHCM

  • Parathyroid hormone (PTH) IVD, control
IGF - IMMULITE - CTL - 2x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385387
In Commercial Distribution

  • 00630414953212 ()
LGCOCM

  • Insulin-like growth factor I (IGF1) IVD, control
ACTH - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385382
In Commercial Distribution

  • 00630414953090 ()
LACCM

  • Adrenocorticotropic hormone (ACTH) IVD, control
DIMENSION® VISTA® 500 Instrument
Siemens Healthcare Diagnostics Inc.
10284473
In Commercial Distribution

  • 00630414949581 ()
1000036563

  • Multiple clinical chemistry analyser IVD, laboratory
Dimension Vista® 1500 Intelligent Lab System
Siemens Healthcare Diagnostics Inc.
10459469
In Commercial Distribution

  • 00630414949536 ()
1000033793

  • Multiple clinical chemistry analyser IVD, laboratory
Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL)
Siemens Healthcare Diagnostics Inc.
10712611
In Commercial Distribution

  • 00630414948775 ()
KC638

  • Total testosterone IVD, calibrator
Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL;2D x 1.0 mL; 2E x 1.0 mL)
Siemens Healthcare Diagnostics Inc.
10712610
In Commercial Distribution

  • 00630414948768 ()
KC637

  • Progesterone IVD, calibrator
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10707265
In Commercial Distribution

  • 00630414947921 ()
LUE3CVM(D)

  • Free estriol (oestriol) IVD, control
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10702834
In Commercial Distribution

  • 00630414947914 ()
L2KE26(D)

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10702833
In Commercial Distribution

  • 00630414947907 ()
L2KE22(D)

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10702832
In Commercial Distribution

  • 00630414947891 ()
LKE21(D)

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
IMMULITE® 1000 Instrument, 110 VOLT
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380058
In Commercial Distribution

  • 00630414947440 ()
030006-03

  • Chemiluminescent immunoassay analyser IVD
The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10459330
In Commercial Distribution

  • 00630414945514 ()
OVOB03

  • Coagulation analyser IVD, laboratory
IMMULITE® 2000 XPi Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10373214
In Commercial Distribution

  • 00630414945422 ()
030002-33

  • Chemiluminescent immunoassay analyser IVD
Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
Siemens Healthcare Diagnostics Inc.
11700159
In Commercial Distribution

  • 00630414321486 ()
  • 00630414652597 ()
11700159

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Atellica IM 1600 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764888
In Commercial Distribution

  • 00630414650623 ()
11066000

  • Chemiluminescent immunoassay analyser IVD
Atellica IM 1300 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764765
In Commercial Distribution

  • 00630414650579 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
Assayed control used to monitor the performance of coagulation assays in the normal range
Siemens Healthcare Diagnostics Products GmbH
10873874
In Commercial Distribution

  • 00842768018909 ()
  • 00630414640747 ()
10873874

  • Multiple coagulation factor IVD, control
Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10873872
In Commercial Distribution

  • 00842768018916 ()
  • 00630414640563 ()
10873872

  • Calcium chloride coagulation reagent IVD
For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873844
In Commercial Distribution

  • 00842768019456 ()
  • 00630414640426 ()
10873844

  • Multiple coagulation factor IVD, control
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873834
In Commercial Distribution

  • 00842768019531 ()
  • 00630414640365 ()
10873834

  • Multiple coagulation factor IVD, control
For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873843
In Commercial Distribution

  • 00842768019463 ()
  • 00630414640280 ()
10873843

  • Multiple coagulation factor IVD, control
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873833
In Commercial Distribution

  • 00842768019548 ()
  • 00630414640259 ()
10873833

  • Multiple coagulation factor IVD, control
For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873842
In Commercial Distribution

  • 00842768019470 ()
  • 00630414640167 ()
10873842

  • Multiple coagulation factor IVD, control
LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873936
In Commercial Distribution

  • 00842768019685 ()
  • 00630414640099 ()
10873936

  • Lupus anticoagulant marker IVD, control
LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873935
In Commercial Distribution

  • 00842768019678 ()
  • 00630414640013 ()
10873935

  • Lupus anticoagulant marker IVD, control
Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10873907
In Commercial Distribution

  • 00842768018893 ()
  • 00630414639772 ()
10873907

  • Multiple coagulation factor IVD, calibrator
LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873904
In Commercial Distribution

  • 00842768019654 ()
  • 00630414639765 ()
10873904

  • Lupus anticoagulant marker IVD, reagent
Assayed control used to monitor the performance of coagulation assays in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10873891
In Commercial Distribution

  • 00842768018589 ()
  • 00630414639703 ()
10873891

  • Multiple coagulation factor IVD, control
LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873902
In Commercial Distribution

  • 00842768019661 ()
  • 00630414639451 ()
10873902

  • Lupus anticoagulant marker IVD, reagent
Atellica IM DHEASII MCM SET
Siemens Healthcare Diagnostics Inc.
11209195
In Commercial Distribution

  • 00630414632940 ()
11209195

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
Atellica IM DHEASII 100T KIT
Siemens Healthcare Diagnostics Inc.
11209193
In Commercial Distribution

  • 00630414632926 ()
11209193

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208875
In Commercial Distribution

  • 00630414624709 ()
11208875

  • Thyroid stimulating hormone (TSH) IVD, control
TSH3-ULII Atellica IM - RGT (REF) 2750T
Siemens Healthcare Diagnostics Inc.
11208704
In Commercial Distribution

  • 00630414624693 ()
11208704

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208876
In Commercial Distribution

  • 00630414624532 ()
11208876

  • Thyroid stimulating hormone (TSH) IVD, control
TSH3-ULII Atellica IM – RGT 550T
Siemens Healthcare Diagnostics Inc.
11208707
In Commercial Distribution

  • 00630414624525 ()
11208707

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM - RGT 110T
Siemens Healthcare Diagnostics Inc.
11208706
In Commercial Distribution

  • 00630414624518 ()
11208706

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
Siemens Healthcare Diagnostics Inc.
11208703
In Commercial Distribution

  • 00630414624501 ()
11208703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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