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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 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® Chemistry Wash - 00842768014277

Chemistry Wash, 1x1.7 L
Siemens Healthcare Diagnostics Inc.
10445052
In Commercial Distribution

  • 00842768014277 ()
RD701

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

Dimension® Flex® reagent cartridge URCA - 00842768014192

Uric Acid Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444967
In Commercial Distribution

  • 00842768014192 ()
  • 00630414004488 ()
DF77

  • Uric acid IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge MG - 00842768014185

Magnesium Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444963
In Commercial Distribution

  • 00842768014185 ()
  • 00630414004457 ()
DF57

  • Magnesium (Mg2+) IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge PCHE - 00842768014178

Pseudocholinesterase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444964
In Commercial Distribution

  • 00842768014178 ()
  • 00630414004464 ()
DF51

  • Pseudocholinesterase IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge GGT - 00842768014154

Y-Glutamyl Transferase Flex® reagent cartridge, 288 (4x72) tests
Siemens Healthcare Diagnostics Inc.
10444960
In Commercial Distribution

  • 00842768014154 ()
  • 00630414004433 ()
DF45A

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge RCRP - 00842768014130

C-Reactive Protein Extended Range Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444903
In Commercial Distribution

  • 00842768014130 ()
  • 00630414003917 ()
DF34

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge CA - 00842768014123

Calcium Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444949
In Commercial Distribution

  • 00842768014123 ()
  • 00630414004358 ()
DF23A

  • Calcium (Ca2+) IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge BUN - 00842768014116

Urea Nitrogen Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444969
In Commercial Distribution

  • 00842768014116 ()
  • 00630414004495 ()
DF21

  • Urea IVD, kit, enzyme spectrophotometry

Dimension® ALDL Calibrator - 00842768014093

ALDL Calibrator, 2x3x2ml
Siemens Healthcare Diagnostics Inc.
10444996
In Commercial Distribution

  • 00842768014093 ()
  • 00630414017037 ()
DC131

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator

Dimension® Cuvette Cartridge - 00842768014086

Cuvette Cartridge - Dimension® - 1 Cartridge
Siemens Healthcare Diagnostics Inc.
10445042
In Commercial Distribution

  • 00842768014086 ()
D828

  • Laboratory analyser cuvette IVD, single-use

Dimension® Sample Transfer Module Aliquot Segments - 00842768014048

Dimension® Sample Transfer Module Aliquot Segments
Siemens Healthcare Diagnostics Inc.
10445571
In Commercial Distribution

  • 00842768014048 ()
  • 00630414024547 ()
STM2

  • General specimen container IVD, no additive/medium

Dimension® Pipette Tips - 00842768014031

Dimension® Sample Transfer Module Pipette Tips
Siemens Healthcare Diagnostics Inc.
10445570
In Commercial Distribution

  • 00842768014031 ()
  • 00630414024530 ()
STM1

  • Pipette tip IVD

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 Sample Diluent - 00842768014017

Sample Diluent, 6x500mL
Siemens Healthcare Diagnostics Inc.
10444874
In Commercial Distribution

  • 00842768014017 ()
  • 00630414003795 ()
S635

  • 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® Reaction Vessels - 00842768013928

Dimension® Heterogenous Immunoassay Module - Reaction Vessels (1000) and Waste Container Liners (5)
Siemens Healthcare Diagnostics Inc.
10445044
In Commercial Distribution

  • 00842768013928 ()
RXV1A

  • Laboratory waste receptacle liner IVD
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