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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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Syva® Emit® II Plus Cannabinoid Assay - 00842768014420

Syva® Emit® II Plus Cannabinoid Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445470
In Commercial Distribution

  • 00842768014420 ()
9N039UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Ethyl Alcohol Assay - 00842768014413

Syva® Emit® II Plus Ethyl Alcohol Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445446
In Commercial Distribution

  • 00842768014413 ()
9K039UL

  • Ethanol (ETOH) IVD, kit, spectrophotometry

Syva® Emit® II Plus Phencyclidine Assay - 00842768014406

Syva® Emit® II Plus Phencyclidine Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445442
In Commercial Distribution

  • 00842768014406 ()
9J039UL

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Cocaine Metabolite Assay - 00842768014390

Syva® Emit® II Plus Cocaine Metabolite Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445438
In Commercial Distribution

  • 00842768014390 ()
9H039UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

Syva® Emit® II Plus Propoxyphene Assay - 00842768014383

Syva® Emit® II Plus Propoxyphene Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445434
In Commercial Distribution

  • 00842768014383 ()
9G039UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Benzodiazepine Assay - 00842768014376

Syva® Emit® II Plus Benzodiazepine Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445430
In Commercial Distribution

  • 00842768014376 ()
9F039UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Methadone Assay - 00842768014369

Syva® Emit® II Plus Methadone Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445427
In Commercial Distribution

  • 00842768014369 ()
9E039UL

  • Methadone IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Barbiturate Assay - 00842768014352

Syva® Emit® II Plus Barbiturate Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445423
In Commercial Distribution

  • 00842768014352 ()
9D039UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Amphetamines Assay - 00842768014345

Syva® Emit® II Plus Amphetamines Assay - 29 mL kit
Siemens Healthcare Diagnostics Inc.
10445418
In Commercial Distribution

  • 00842768014345 ()
9C039UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Opiate Assay - 00842768014338

Syva® Emit® II Plus Opiate Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445414
In Commercial Distribution

  • 00842768014338 ()
9B039UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls - 00842768014321

Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls, 3 levels
Siemens Healthcare Diagnostics Inc.
10445390
In Commercial Distribution

  • 00842768014321 ()
7C219UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® tox™ Serum Tricyclic Antidepressants Assay - 00842768014314

Syva® Emit® tox Serum Tricyclic Antidepressants Assay
Siemens Healthcare Diagnostics Inc.
10445389
In Commercial Distribution

  • 00842768014314 ()
7C209UL

  • Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)

Dimension® QuikLYTE® Multisensor Flush Solution - 00842768014307

Flush Solution, 3x1000mL
Siemens Healthcare Diagnostics Inc.
10445051
In Commercial Distribution

  • 00842768014307 ()
  • 00630414004686 ()
S630

  • Multiple electrolyte IVD, reagent

Dimension® QuikLYTE® Multisensor Na+/K+/Cl- - 00842768014291

QuikLYTE® Integrated Multisensor
Siemens Healthcare Diagnostics Inc.
10445058
In Commercial Distribution

  • 00842768014291 ()
  • 00630414004693 ()
S600

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

Dimension® QuikLYTE® Integrated Multisensor Diluent Check - 00842768014024

Quiklyte Diluent Check, 60mL
Siemens Healthcare Diagnostics Inc.
10444872
In Commercial Distribution

  • 00842768014024 ()
S640

  • Multiple electrolyte IVD, reagent

Dimension® QuikLYTE® Integrated Multisensor Standard B - 00842768014000

QuikLYTE® Integrated Multisensor Standard B, 3x300mL
Siemens Healthcare Diagnostics Inc.
10444881
In Commercial Distribution

  • 00842768014000 ()
  • 00630414003818 ()
S625

  • Multiple electrolyte IVD, calibrator

Dimension® QuikLYTE® Integrated Multisensor Standard A - 00842768013997

QuikLYTE® Integrated Multisensor Standard A, 3x1 Liter
Siemens Healthcare Diagnostics Inc.
10444878
In Commercial Distribution

  • 00842768013997 ()
  • 00630414003801 ()
S620

  • Multiple electrolyte IVD, calibrator

Dimension Human Chorionic Gonadotropin Flex reagent cartridge - 00842768013911

Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444914
In Commercial Distribution

  • 00842768013911 ()
  • 00630414004013 ()
RF530

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Dimension Cardiac Troponin-I Flex reagent cartridge - 00842768013904

Cardiac Troponin-I Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10444896
In Commercial Distribution

  • 00842768013904 ()
  • 00630414003870 ()
RF521

  • Troponin I IVD, kit, enzyme immunoassay (EIA)

Dimension® clinical chemistry system FPSA Flex® reagent cartridge - 00842768013881

Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10444888
In Commercial Distribution

  • 00842768013881 ()
  • 00630414601755 ()
RF452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG - 00842768013850

Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444913
In Commercial Distribution

  • 00842768013850 ()
  • 00630414004006 ()
RF430

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO - 00842768013843

Myoglobin Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444907
In Commercial Distribution

  • 00842768013843 ()
  • 00630414003955 ()
RF422A

  • Myoglobin IVD, kit, enzyme immunoassay (EIA)

Dimension Cardiac Troponin-I Flex reagent cartridge - 00842768013836

Cardiac Troponin-I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444905
In Commercial Distribution

  • 00842768013836 ()
  • 00630414003931 ()
RF421C

  • Troponin I IVD, kit, enzyme immunoassay (EIA)

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge - 00842768013829

Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge TSH - 00842768013805

Thyroid Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10444911
In Commercial Distribution

  • 00842768013805 ()
  • 00630414003986 ()
RF412

  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge FT4 - 00842768013799

Free Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444910
In Commercial Distribution

  • 00842768013799 ()
  • 00630414003979 ()
RF410

  • Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

Dimension® Sample Probe Cleaner - 00842768013775

Sample Probe Cleaner, 1x1 Liter
Siemens Healthcare Diagnostics Inc.
10445035
In Commercial Distribution

  • 00842768013775 ()
RD703

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension® clinical chemistry system T/F PSA Calibrator - 00842768013751

Heterogeneous Immunoassay Module Total/Free Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10445031
In Commercial Distribution

  • 00842768013751 ()
RC452

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension® FERR Calibrator - 00842768013744

Ferritin Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445017
In Commercial Distribution

  • 00842768013744 ()
  • 00630414017136 ()
RC440

  • Ferritin IVD, calibrator

Dimension® HCG Calibrator - 00842768013737

Human Chorionic Gonadotropin Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445019
In Commercial Distribution

  • 00842768013737 ()
  • 00630414017150 ()
RC430

  • Total human chorionic gonadotropin IVD, calibrator
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