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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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Ready Sensor™ Hct Biosensor for in vitro use on the RapidLab® 348/348ex pH/Blood Gas Analyzers.
Siemens Healthcare Diagnostics Inc.
10309783
In Commercial Distribution

  • 00630414056296 ()
106042

  • Multiple blood gas analyte IVD, calibrator
For in vitro diagnostics use for calibration of the RapidLab® 348/348ex pH/Blood Gas Analyzers
Siemens Healthcare Diagnostics Inc.
10309768
In Commercial Distribution

  • 00630414055657 ()
105070

  • Multiple blood gas analyte IVD, calibrator
RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent
Siemens Healthcare Diagnostics Inc.
10309757
In Commercial Distribution

  • 00630414053455 ()
104227

  • Multiple blood gas analyte IVD, calibrator
Lyphochek Urine Metals Control MiniPak (A human urine assayed metals control.)
BIO-RAD LABORATORIES, INC.
402X
In Commercial Distribution

  • 00847661004073 ()
402X

  • Multiple heavy metal IVD, control
Lyphochek Whole Blood Metals Control MiniPak (A human whole blood assayed metals control.)
BIO-RAD LABORATORIES, INC.
528X
In Commercial Distribution

  • 00847661001843 ()
528X

  • Multiple heavy metal IVD, control
Lyphochek Whole Blood Metals Control Level 2 (A human whole blood assayed metals control.)
BIO-RAD LABORATORIES, INC.
528
In Commercial Distribution

  • 00847661001690 ()
528

  • Multiple heavy metal IVD, control
Lyphochek Whole Blood Metals Control Level 1 (A human whole blood assayed metals control.)
BIO-RAD LABORATORIES, INC.
527
In Commercial Distribution

  • 00847661001683 ()
527

  • Multiple heavy metal IVD, control
Lyphochek Urine Metals Control Level 2 (A human urine assayed metals control.)
BIO-RAD LABORATORIES, INC.
405
In Commercial Distribution

  • 00847661000297 ()
405

  • Multiple heavy metal IVD, control
Lyphochek Urine Metals Control Level 1 (A human urine assayed metals control.)
BIO-RAD LABORATORIES, INC.
400
In Commercial Distribution

  • 00847661000280 ()
400

  • Multiple heavy metal IVD, control
Lyphochek Whole Blood Metals Control Level 3 (A human whole blood assayed metals control.)
BIO-RAD LABORATORIES, INC.
529
In Commercial Distribution

  • 00847661001706 ()
529

  • Multiple heavy metal IVD, control
Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator
Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285904
In Commercial Distribution

  • 00630414555324 ()
4800735

  • Multiple human hormone IVD, calibrator
Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10285903
In Commercial Distribution

  • 00630414555317 ()
4800646

  • Multiple human hormone IVD, calibrator
HCG Total - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10308986
In Commercial Distribution

  • 00630414504797 ()
649625

  • Multiple human hormone IVD, calibrator
Total HCG B (6PK) (US) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10331729
In Commercial Distribution

  • 00630414504773 ()
652707

  • Multiple human hormone IVD, calibrator
Total HCG B (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10331732
In Commercial Distribution

  • 00630414504759 ()
654254

  • Multiple human hormone IVD, calibrator
RAPIDLab® 1200 Systems Wash Cartridge, for in vitro diagnostic use with RAPIDLab® 1200 series systems
Siemens Healthcare Diagnostics Inc.
10319817
In Commercial Distribution

  • 00630414492612 ()
3913056

  • Multiple blood gas analyte IVD, calibrator
Calibrator B - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206242
In Commercial Distribution

  • 00630414294094 ()
  • 00630414293547 ()
11206242

  • Multiple human hormone IVD, calibrator
Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206241
In Commercial Distribution

  • 00630414294087 ()
  • 00630414293530 ()
11206241

  • Multiple human hormone IVD, calibrator
Calibrating Gas Kit for Siemens Healthcare Diagnostics Blood Gas Systems that use gas regulators without metering valves.
Siemens Healthcare Diagnostics Inc.
10318934
In Commercial Distribution

  • 00630414196701 ()
116769

  • Multiple blood gas analyte IVD, calibrator
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