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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AMH – Atellica IM – RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998433
In Commercial Distribution

  • 00842768022401 ()
10998433

  • Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay
AMH – Atellica IM - Master Curve Material Kit 4 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998431
In Commercial Distribution

  • 00842768022395 ()
10998431

  • Anti-Mullerian hormone (AMH) IVD, control
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)
Direct Bilirubin Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10444956
In Commercial Distribution

  • 00842768020551 ()
  • 00630414004389 ()
DF125

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Total Bilirubin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444957
In Commercial Distribution

  • 00842768020544 ()
  • 00630414004402 ()
DF167

  • Total bilirubin IVD, kit, spectrophotometry
Lipid Calibrator, 3x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10464345
In Commercial Distribution

  • 00842768020452 ()
KC220A

  • Multiple lipid analyte IVD, calibrator
High Density Lipoprotein Cholesterol Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10464340
In Commercial Distribution

  • 00842768020438 ()
  • 00630414005584 ()
K3048A

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444945
In Commercial Distribution

  • 00842768020414 ()
  • 00630414004327 ()
DF85

  • Iron IVD, kit, spectrophotometry
Syva® Emit® II LSD Assay
Siemens Healthcare Diagnostics Inc.
10445455
In Commercial Distribution

  • 00842768020315 ()
9L039UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, kit, enzyme immunoassay (EIA)
Liquid Lipase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10461745
Not in Commercial Distribution

  • 00842768020223 ()
  • 00630414005485 ()
K3056

  • Lipase IVD, kit, spectrophotometry
Alpha-Fetoprotein Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10463378
In Commercial Distribution

  • 00842768019937 ()
  • 00630414005515 ()
K6454

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Carcinoembryonic Antigen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10461744
In Commercial Distribution

  • 00842768019920 ()
  • 00630414005478 ()
K6453

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Ethyl Alcohol Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10445109
In Commercial Distribution

  • 00842768019913 ()
  • 00630414004822 ()
K5022

  • Ethanol (ETOH) IVD, kit, spectrophotometry
The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ pBNP method.
Siemens Healthcare Diagnostics Inc.
10445087
In Commercial Distribution

  • 00842768019722 ()
  • 00630414009971 ()
CPBNPM-C

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care(TM) NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma and is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445086
In Commercial Distribution

  • 00842768019715 ()
  • 00630414009964 ()
CPBNPM

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
IRON Calibrator, 2x2x1.2mL
Siemens Healthcare Diagnostics Inc.
10445010
In Commercial Distribution

  • 00842768019616 ()
DC85

  • Iron IVD, calibrator
Total Bilirubin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444938
Not in Commercial Distribution

  • 00842768018312 ()
  • 00630414004259 ()
DF107

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Mass Creatine Kinase MB Isoenzyme Calibrator, 2x4x1mL / 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10445195
In Commercial Distribution

  • 00842768017919 ()
KC672

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Emit ® 2000 N-Acetylprocainamide Assay
Siemens Healthcare Diagnostics Inc.
10445321
In Commercial Distribution

  • 00842768017421 ()
4N019UL

  • N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay
Syva® Emit® 2000 Phenobarbital Calibrators
Siemens Healthcare Diagnostics Inc.
10445307
In Commercial Distribution

  • 00842768017414 ()
4D109UL

  • Phenobarbital IVD, calibrator
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