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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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IMMULITE® 2000 Systems Microsampling Tubes - 00630414973937

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

  • 00630414973937 ()
LMST

  • General specimen container IVD, no additive/medium

IMMULITE® 2000 Systems Diluent Tubes - 00630414973159

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385210
In Commercial Distribution

  • 00630414973159 ()
L2ZT

  • General specimen container IVD, no additive/medium

IMMULITE®2000 Systems Diluent Tube Caps - 00630414972923

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385211
In Commercial Distribution

  • 00630414972923 ()
L2ZC

  • General specimen container IVD, no additive/medium

IMMULITE® 2000 Systems Allergen Tubes - 00630414965741

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 Caps - 00630414965734

IMMULITE® 2000 Systems Allergen Tube Cap
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10282837
In Commercial Distribution

  • 00630414965734 ()
L2ATC

  • General specimen container IVD, no additive/medium

IMMULITE® 2000 Systems Reaction Tubes - 00630414954547

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 - 00630414949581

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 - 00630414949536

Dimension Vista® 1500 Intelligent Lab System
Siemens Healthcare Diagnostics Inc.
10459469
In Commercial Distribution

  • 00630414949536 ()
1000033793

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension Vista® Testosterone Calibrator - 00630414948775

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

Dimension Vista® PROG Calibrator - 00630414948768

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

Dimension Vista® CHEM 1 CAL - 00630414948508

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

Dimension® CHEM I CAL - 00630414948492

Chemistry I Calibrator, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10716280
In Commercial Distribution

  • 00630414948492 ()
DC18C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Flex® reagent cartridge AMM - 00630414948102

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711992
In Commercial Distribution

  • 00630414948102 ()
  • 00630414006093 ()
K3119

  • Ammonia IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge AMM - 00630414948096

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

  • 00630414948096 ()
  • 00630414006086 ()
DF119

  • Ammonia IVD, kit, spectrophotometry

Dimension® CHEM III CAL - 00630414948034

Chemistry III Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10711580
In Commercial Distribution

  • 00630414948034 ()
DC130

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CHEM 3 CAL - 00630414948027

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 - 00630414947556

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 - 00630414947549

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 - 00630414947532

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 - 00630414947525

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
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