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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Microsampling Tubes - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385207
In Commercial Distribution

  • 00630414973937 ()
LMST

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385210
In Commercial Distribution

  • 00630414973159 ()
L2ZT

  • General specimen container IVD, no additive/medium
No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385211
In Commercial Distribution

  • 00630414972923 ()
L2ZC

  • General specimen container IVD, no additive/medium
Allergen Tube Septa
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10282849
In Commercial Distribution

  • 00630414965741 ()
L2ATS2

  • General specimen container IVD, no additive/medium
IMMULITE® 2000 Systems Allergen Tube Cap
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10282837
In Commercial Distribution

  • 00630414965734 ()
L2ATC

  • General specimen container IVD, no additive/medium
Gear Driven Reaction Tubes 1000 - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385206
In Commercial Distribution

  • 00630414954547 ()
LRXT

  • General specimen container IVD, no additive/medium
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
Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)
Siemens Healthcare Diagnostics Inc.
10716281
Not in Commercial Distribution

  • 00630414948508 ()
KC110B

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Chemistry I Calibrator, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10716280
In Commercial Distribution

  • 00630414948492 ()
DC18C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711992
In Commercial Distribution

  • 00630414948102 ()
  • 00630414006093 ()
K3119

  • Ammonia IVD, kit, spectrophotometry
Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711991
In Commercial Distribution

  • 00630414948096 ()
  • 00630414006086 ()
DF119

  • Ammonia IVD, kit, spectrophotometry
Chemistry III Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10711580
In Commercial Distribution

  • 00630414948034 ()
DC130

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Chemistry 3 Calibrator, 6 (3A x 2.5 mL; 3B x 2.5 mL)
Siemens Healthcare Diagnostics Inc.
10711579
In Commercial Distribution

  • 00630414948027 ()
KC130A

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
RAPIDPoint® 500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10844813
In Commercial Distribution

  • 00630414947556 ()
10844813

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10844812
In Commercial Distribution

  • 00630414947549 ()
10844812

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10844811
In Commercial Distribution

  • 00630414947532 ()
10844811

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 analyzer.
Siemens Healthcare Diagnostics Inc.
10844810
In Commercial Distribution

  • 00630414947525 ()
10844810

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
IMMULITE® 1000 Instrument, 110 VOLT
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380058
In Commercial Distribution

  • 00630414947440 ()
030006-03

  • Chemiluminescent immunoassay analyser IVD
ALBP KIT - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10711842
In Commercial Distribution

  • 00630414947426 ()
  • 00630414006079 ()
10711842

  • Albumin IVD, calibrator
Albumin - ADVIA Chem. - RGT - 4x1525
Siemens Healthcare Diagnostics Inc.
10711841
In Commercial Distribution

  • 00630414947419 ()
  • 00630414006055 ()
10711841

  • Albumin IVD, kit, spectrophotometry
Albumin - ADVIA Chem. - RGT - 4x800
Siemens Healthcare Diagnostics Inc.
10711840
In Commercial Distribution

  • 00630414947402 ()
  • 00630414006031 ()
10711840

  • Albumin IVD, kit, spectrophotometry
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
Protein 1 Calibrator
Siemens Healthcare Diagnostics Inc.
11537520
In Commercial Distribution

  • 00630414313467 ()
  • 00630414636672 ()
11537520

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
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
Test Strips for the Determination of Albumin and Creatinine in Urine
Siemens Healthcare Diagnostics Inc.
11643376
In Commercial Distribution

  • 00630414317434 ()
  • 00630414631707 ()


  • Urine protein IVD, kit, rapid colorimetric, clinical
Test strips for urinary tract infection
Siemens Healthcare Diagnostics Inc.
11643375
In Commercial Distribution

  • 00630414317427 ()
  • 00630414631677 ()
11643375

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Gamma-Glutamyl Transferase (GGT_2) Reagents
Siemens Healthcare Diagnostics Inc.
11537248
In Commercial Distribution

  • 00630414313382 ()
  • 00630414628707 ()
11537248

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
PBNPII - ATELLICA IM - MCM Set
Siemens Healthcare Diagnostics Inc.
11204754
In Commercial Distribution

  • 00630414626970 ()
11204754

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
PBNPII - ADVIA Centaur - MCM Set
Siemens Healthcare Diagnostics Inc.
11204753
In Commercial Distribution

  • 00630414626963 ()
11204753

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
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
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