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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Emit® 2000 N-Acetylprocainamide Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445323
In Commercial Distribution

  • 00842768023279 ()
4N229

  • N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay
Emit® 2000 Procainamide Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445320
In Commercial Distribution

  • 00842768023262 ()
4K229

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 Valproic Acid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445314
In Commercial Distribution

  • 00842768023248 ()
4G229

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Carbamazepine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445311
In Commercial Distribution

  • 00842768023231 ()
4F229

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Phenobarbital Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445308
In Commercial Distribution

  • 00842768023224 ()
4D229

  • Phenobarbital IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Phenytoin Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445305
In Commercial Distribution

  • 00842768023217 ()
4A229

  • Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Herpes-1 IgG (HSV1) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733032
In Commercial Distribution

  • 00842768022791 ()
10733032

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
Herpes-1 IgG (HSV1) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733031
In Commercial Distribution

  • 00842768022784 ()
10733031

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
AMH – Atellica IM – RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998433
In Commercial Distribution

  • 00842768022401 ()
10998433

  • Anti-Mullerian hormone (AMH) 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
N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445008
In Commercial Distribution

  • 00842768016912 ()
  • 00630414017105 ()
RC423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
Cardiac Troponin I Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10445197
Not in Commercial Distribution

  • 00842768016738 ()
KC678

  • Troponin I IVD, calibrator
Free Prostate Specific Antigen Flex® reagent cartridge 80 Test
Siemens Healthcare Diagnostics Inc.
10445091
In Commercial Distribution

  • 00842768016677 ()
  • 00630414601786 ()
K6452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Folate Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445138
In Commercial Distribution

  • 00842768016653 ()
  • 00630414005072 ()
K6444

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator
Drugs of Abuse Negative Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445199
In Commercial Distribution

  • 00842768016479 ()
  • 00630414005294 ()
KC516

  • Multiple drugs of abuse IVD, control
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