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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VERSANT® Sample Preparation 1.2 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10629800
Not in Commercial Distribution

  • 00630414587134 ()
10629800

  • Nucleic acid extraction/isolation kit IVD
Vitamin D Diluent (2PK) - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10494100
In Commercial Distribution

  • 00630414586212 ()
  • 00630414005904 ()
10494100

  • Buffered sample diluent IVD
Ferritin - ADVIA Chem. - RGT - 4x800 tests
Siemens Healthcare Diagnostics Inc.
10494078
In Commercial Distribution

  • 00630414586069 ()
10494078

  • Ferritin IVD, kit, nephelometry/turbidimetry
ADVIA® CENTAUR® XP Refurbished Instrument
Siemens Healthcare Diagnostics Inc.
10471899
In Commercial Distribution

  • 00630414585475 ()
078-A011R03

  • Chemiluminescent immunoassay analyser IVD
PTH intact - CENTAUR - RGT - 500 tests (REF)
Siemens Healthcare Diagnostics Inc.
10493616
In Commercial Distribution

  • 00630414585352 ()
10493616

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
PTH intact - CENTAUR - RGT - 500 tests (REF)
Siemens Healthcare Diagnostics Inc.
10493615
In Commercial Distribution

  • 00630414585345 ()
10493615

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Vitamin D - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10493589
In Commercial Distribution

  • 00630414585093 ()
10493589

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator
ADVIA®2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10285572
In Commercial Distribution

  • 00630414582047 ()
067-A021-01

  • Haematological cell analyser IVD
ADVIA® 2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10488923
In Commercial Distribution

  • 00630414581965 ()
067-A014-01

  • Haematological cell analyser IVD
TG Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492692
In Commercial Distribution

  • 00630414580722 ()
10492692

  • Thyroglobulin antibody IVD, control
Testosterone 2 Master Curve Material SET - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492623
In Commercial Distribution

  • 00630414580654 ()
10492623

  • Total testosterone IVD, control
Syphillis - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10492616
In Commercial Distribution

  • 00630414580616 ()
10492616

  • Treponema pallidum total antibody IVD, control
Syphilis - CENTAUR - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10492493
In Commercial Distribution

  • 00630414580173 ()
10492493

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
IgE - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10492491
In Commercial Distribution

  • 00630414580111 ()
10492491

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator
TG Ab - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10492399
In Commercial Distribution

  • 00630414579221 ()
  • 00630414005898 ()
10492399

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
TG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10492398
In Commercial Distribution

  • 00630414579214 ()
10492398

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
PTH Intact - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10492394
In Commercial Distribution

  • 00630414579207 ()
10492394

  • Parathyroid hormone (PTH) IVD, calibrator
PTH Intact - CENTAUR - CAL - 6x2x1mL
Siemens Healthcare Diagnostics Inc.
10492387
In Commercial Distribution

  • 00630414579191 ()
10492387

  • Parathyroid hormone (PTH) IVD, calibrator
PTH Intact - CENTAUR - CTL - 3x2x2mL
Siemens Healthcare Diagnostics Inc.
10492378
In Commercial Distribution

  • 00630414579184 ()
10492378

  • Parathyroid hormone (PTH) IVD, control
PTH Intact Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492373
In Commercial Distribution

  • 00630414579177 ()
10492373

  • Parathyroid hormone (PTH) IVD, control
PTH intact - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10492369
In Commercial Distribution

  • 00630414579160 ()
  • 00630414027678 ()
10492369

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
PTH intact - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10492368
In Commercial Distribution

  • 00630414579153 ()
10492368

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Enhanced Liver Fibrosis (ELF) QC Kit - ADVIA Centaur - CLT 3 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10492342
In Commercial Distribution

  • 00630414579108 ()
10492342

  • Multiple liver fibrosis marker IVD, control
Enhanced Estradiol 2 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492322
In Commercial Distribution

  • 00630414578972 ()
10492322

  • Estradiol (oestradiol) (E2) IVD, control
Glucose - ADVIA Chem. - RGT - 2450/2030 tests
Siemens Healthcare Diagnostics Inc.
10492319
In Commercial Distribution

  • 00630414578941 ()
  • 00630414005881 ()
10492319

  • Glucose IVD, kit, spectrophotometry
Estradiol - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10379811
In Commercial Distribution

  • 00630414578491 ()
10379811

  • Multiple steroid hormone IVD, calibrator
Estradiol - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10379810
In Commercial Distribution

  • 00630414578484 ()
10379810

  • Multiple steroid hormone IVD, calibrator
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376323
In Commercial Distribution

  • 00630414578330 ()
10376323

  • Urine analyser IVD, point-of-care
HBsAgII (HBsII) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10492138
In Commercial Distribution

  • 00630414578170 ()
10492138

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
CA 19-9 bottle - CENTAUR - CONS - 1x25mL
Siemens Healthcare Diagnostics Inc.
10491974
In Commercial Distribution

  • 00630414577135 ()
10491974

  • Buffered sample diluent IVD
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