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 Class Implantable

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Sirolimus Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10464327
In Commercial Distribution

  • 00842768022128 ()
DC306

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator
Sirolimus Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10464331
In Commercial Distribution

  • 00842768022111 ()
  • 00630414005546 ()
DF306

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
LOCI Free Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464523
In Commercial Distribution

  • 00842768022098 ()
  • 00630414005652 ()
RF610

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10464524
In Commercial Distribution

  • 00842768022081 ()
  • 00630414005669 ()
RF612

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
LOCI Cardiac Troponin I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10464336
In Commercial Distribution

  • 00842768022074 ()
RC621

  • Troponin I IVD, calibrator
Cardiac Troponin I Flex® reagent cartridge, 144 tests
Siemens Healthcare Diagnostics Inc.
10464525
In Commercial Distribution

  • 00842768022067 ()
  • 00630414005676 ()
RF621

  • Troponin I IVD, kit, chemiluminescent immunoassay
Ethyl Alcohol Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10459408
In Commercial Distribution

  • 00842768022050 ()
  • 00630414005447 ()
DF22

  • Ethanol (ETOH) IVD, kit, spectrophotometry
High Density Lipoprotein Cholesterol Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10464332
In Commercial Distribution

  • 00842768022029 ()
  • 00630414005553 ()
DF48B

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
AHDL Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10464328
In Commercial Distribution

  • 00842768022012 ()
DC48B

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
Syva® Emit® II Plus Ecstasy Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445478
In Commercial Distribution

  • 00842768021947 ()
9X129UL

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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