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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Insulin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387066
In Commercial Distribution

  • 00630414954035 ()
L2INZ

  • Buffered sample diluent IVD
Insulin Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387034
In Commercial Distribution

  • 00630414954028 ()
LINZ

  • Buffered sample diluent IVD
IGG/IGM Torch Diluent - IMMULITE
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387663
In Commercial Distribution

  • 00630414953953 ()
L2IGZ2

  • Buffered sample diluent IVD
IGF-1 sample diluent - IMMULITE 2000 -
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387074
In Commercial Distribution

  • 00630414953922 ()
L2GFZ

  • Buffered sample diluent IVD
Homocysteine Sample Diluent - IMMULITE 2000 - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387055
In Commercial Distribution

  • 00630414953892 ()
L2HOZ

  • Buffered sample diluent IVD
HCG Sample Diluent - IMMULITE - 1x50mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387051
In Commercial Distribution

  • 00630414953861 ()
L2CGZ

  • Buffered sample diluent IVD
HGH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387030
In Commercial Distribution

  • 00630414953809 ()
LGHZ

  • Buffered sample diluent IVD
Gastrin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386986
In Commercial Distribution

  • 00630414953793 ()
LGAZ

  • Buffered sample diluent IVD
FSH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387064
In Commercial Distribution

  • 00630414953786 ()
L2FSZ

  • Buffered sample diluent IVD
FSH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387026
In Commercial Distribution

  • 00630414953779 ()
LFSZ

  • Buffered sample diluent IVD
Ferritin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387025
In Commercial Distribution

  • 00630414953748 ()
LFEZ

  • Buffered sample diluent IVD
Estradiol Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387063
In Commercial Distribution

  • 00630414953731 ()
L2E2Z

  • Buffered sample diluent IVD
Estradiol Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387021
In Commercial Distribution

  • 00630414953724 ()
LE2Z

  • Buffered sample diluent IVD
DHEA-S Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387020
In Commercial Distribution

  • 00630414953694 ()
LDSZ

  • Buffered sample diluent IVD
CRP sample diluent - IMMULITE 2000-
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387052
In Commercial Distribution

  • 00630414953687 ()
L2CRZ

  • Buffered sample diluent IVD
CRP Sample Diluent - IMMULITE - 1x100mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386982
In Commercial Distribution

  • 00630414953670 ()
LCRZ4

  • Buffered sample diluent IVD
C-Peptide Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387068
In Commercial Distribution

  • 00630414953663 ()
L2PEZ

  • Buffered sample diluent IVD
C-Peptide Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387039
In Commercial Distribution

  • 00630414953656 ()
LPEZ

  • Buffered sample diluent IVD
Cortisol Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386981
In Commercial Distribution

  • 00630414953649 ()
LCOZ

  • Buffered sample diluent IVD
CEA Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387047
In Commercial Distribution

  • 00630414953625 ()
LCEZ

  • Buffered sample diluent IVD
Calcitonin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387019
In Commercial Distribution

  • 00630414953618 ()
LCLZ

  • Buffered sample diluent IVD
CA 15-3 Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387018
In Commercial Distribution

  • 00630414953601 ()
LBRZ

  • Buffered sample diluent IVD
Albumin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387031
In Commercial Distribution

  • 00630414953526 ()
LHAZ

  • Buffered sample diluent IVD
AF AFP Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387015
In Commercial Distribution

  • 00630414953519 ()
LAPZ

  • Buffered sample diluent IVD
ACTH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387014
In Commercial Distribution

  • 00630414953502 ()
LACZ

  • Buffered sample diluent IVD
3G Allergy Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10283033
In Commercial Distribution

  • 00630414953496 ()
L2UNZ

  • Buffered sample diluent IVD
IgE total - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385349
In Commercial Distribution

  • 00630414953458 ()
IECM

  • Total immunoglobulin E (IgE total) IVD, control
Serum Drug - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385397
In Commercial Distribution

  • 00630414953410 ()
SDCM

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Thyroid Autoab - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385381
In Commercial Distribution

  • 00630414953335 ()
LAACM

  • Thyroglobulin IVD, control
TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385395
In Commercial Distribution

  • 00630414953311 ()
LTGCM

  • Thyroid stimulating hormone (TSH) IVD, control
TBG - IMMULITE - CTL - 2x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385244
In Commercial Distribution

  • 00630414953298 ()
LTBCM

  • Thyroxine binding globulin (TBG) IVD, control
Pyrilinks-D - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385243
In Commercial Distribution

  • 00630414953281 ()
LPDCM

  • Collagen pyridium crosslink 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
HCG - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385358
In Commercial Distribution

  • 00630414953205 ()
LCGCM

  • Total human chorionic gonadotropin IVD, control
Gastrin - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385331
In Commercial Distribution

  • 00630414953199 ()
LGACM

  • Gastrin IVD, control
IMMULITE® Systems CRP CONTROL C-Reactive Protein
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385316
In Commercial Distribution

  • 00630414953144 ()
LCRCM

  • C-reactive protein (CRP) IVD, control
IMMULITE® Systems CONTROL Calcitonin
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385383
In Commercial Distribution

  • 00630414953120 ()
LCLCM

  • Calcitonin IVD, control
Albumin - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385388
In Commercial Distribution

  • 00630414953106 ()
LHACM

  • Albumin IVD, control
ACTH - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385382
In Commercial Distribution

  • 00630414953090 ()
LACCM

  • Adrenocorticotropic hormone (ACTH) IVD, control
For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873880
In Commercial Distribution

  • 00842768018831 ()
  • 00630414640761 ()
10873880

  • Coagulation factor VIII IVD, reagent
For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873881
In Commercial Distribution

  • 00842768018824 ()
  • 00630414640587 ()
10873881

  • Coagulation factor IX IVD, reagent
Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873841
In Commercial Distribution

  • 00842768019487 ()
  • 00630414640396 ()
10873841

  • Coagulation inhibitory substance neutralization IVD, reagent
Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873838
In Commercial Distribution

  • 00842768019500 ()
  • 00630414640372 ()
10873838

  • Fibrinogen assay (factor I) IVD, reagent
Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873839
In Commercial Distribution

  • 00842768019494 ()
  • 00630414640273 ()
10873839

  • Buffered sample diluent IVD
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873833
In Commercial Distribution

  • 00842768019548 ()
  • 00630414640259 ()
10873833

  • Multiple coagulation factor IVD, control
INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
10873855
In Commercial Distribution

  • 00630414640181 ()
10873855

  • D-dimer 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
Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10873836
In Commercial Distribution

  • 00842768019524 ()
  • 00630414640150 ()
10873836

  • Fibrinogen assay (factor I) IVD, control
Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873937
In Commercial Distribution

  • 00630414640105 ()
10873937

  • Fibrinogen assay (factor I) IVD, kit, clotting
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