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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 6-Acetylmorphine Assay - 00842768034121

Syva® Emit® II Plus 6-Acetylmorphine Assay - 1 L kit
Siemens Healthcare Diagnostics Inc.
10481483
In Commercial Distribution

  • 00842768034121 ()
9R129UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus 6-Acetylmorphine Assay - 00842768034114

Syva® Emit® II Plus 6-Acetylmorphine Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10470440
In Commercial Distribution

  • 00842768034114 ()
9R039UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® LOCI 4 CAL - 00842768033827

LOCI 4 Calibrator, 10 (2A x 2.0 mL; 2B x 2.0 mL; 2C x 2.0 mL;2D x 2.0 mL; 2E x 2.0 mL)
Siemens Healthcare Diagnostics Inc.
10476172
In Commercial Distribution

  • 00842768033827 ()
KC640A

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Flex® reagent cartridge VB12 - 00842768033810

LOCI Vitamin B12 Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10475489
In Commercial Distribution

  • 00842768033810 ()
  • 00630414005737 ()
K6442A

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

Dimension Vista® DGTX CAL - 00842768033322

DGTX Calibrator, 2x5x5.0mL
Siemens Healthcare Diagnostics Inc.
10636333
In Commercial Distribution

  • 00842768033322 ()
KC470

  • Digitoxin therapeutic drug monitoring IVD, calibrator

Dimension Vista® Flex® reagent cartridge DGTX - 00842768033315

Digitoxin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10482947
In Commercial Distribution

  • 00842768033315 ()
  • 00630414005775 ()
K4036A

  • Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge CHK - 00842768033124

CHK Flex® reagent cartridge, 8 Flex® reagent cartridges
Siemens Healthcare Diagnostics Inc.
10481507
In Commercial Distribution

  • 00842768033124 ()
  • 00630414005751 ()
DF179

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

Dimension Vista® Flex® reagent cartridge CHK - 00842768033117

CHK Flex® reagent cartridge, 4 Flex® reagent cartridge
Siemens Healthcare Diagnostics Inc.
10481508
In Commercial Distribution

  • 00842768033117 ()
  • 00630414005768 ()
KS996

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

Dimension® EXL™ LOCI® Module Flex® reagent cartridge FT3 - 00842768032622

LOCI Free Triiodothyronine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10483414
In Commercial Distribution

  • 00842768032622 ()
  • 00630414005782 ()
RF616

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Dimension® Flex Reagent Cartridge HB1C - 00842768032615

Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator
Siemens Healthcare Diagnostics Inc.
10483822
Not in Commercial Distribution

  • 00842768032615 ()
  • 00630414005805 ()
DF105A

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Dimension® EXL™/ Dimension Vista® MULTI 2 SDIL - 00842768032417

Dimension® EXL™/ Dimension Vista® Multi 2 sample diluent, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10483586
In Commercial Distribution

  • 00842768032417 ()
  • 00630414005799 ()
KD694

  • Buffered sample diluent IVD

Dimension® THYR CAL - 00842768031694

LOCI Thyroid Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10484354
In Commercial Distribution

  • 00842768031694 ()
RC610A

  • Multiple thyroid marker IVD, calibrator

Dimension® Flex® reagent cartridge EZCR - 00842768030512

Enzymatic Creatinine Flex® reagent cartridge, 448 tests
Siemens Healthcare Diagnostics Inc.
10471520
In Commercial Distribution

  • 00842768030512 ()
  • 00630414005713 ()
DF270B

  • Creatinine IVD, kit, spectrophotometry

Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- - 00842768030413

V-LYTE Integrated Multisensor
Siemens Healthcare Diagnostics Inc.
10484429
In Commercial Distribution

  • 00842768030413 ()
K800A

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

Dimension Vista® MULTI 1 SDIL - 00842768030314

Multi 1 Sample Diluent, 12x2mL
Siemens Healthcare Diagnostics Inc.
10469971
In Commercial Distribution

  • 00842768030314 ()
  • 00630414005690 ()
KD693

  • Buffered sample diluent IVD

Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent - 00842768030048

Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10488260
In Commercial Distribution

  • 00842768030048 ()
  • 00630414010526 ()
8S079UL

  • Multiple immunosuppressant therapeutic drug monitoring IVD, reagent

Dimension® EXL™ with LM Integrated Chemistry System - 00842768030024

Dimension® EXL with LM system
Siemens Healthcare Diagnostics Inc.
10472176
In Commercial Distribution

  • 00842768030024 ()
778021.931

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension Vista® Flex® reagent cartridge HbA1c KIT - 00842768029974

HbA1c Kit containing Hemoglobin A1c Flex® reagent cartridge, 240 tests, and HbA1c Calibrator (5 levels)
Siemens Healthcare Diagnostics Inc.
10470481
Not in Commercial Distribution

  • 00842768029974 ()
  • 00630414005706 ()
K3105A

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Dimension® EXL™ LOCI® Module Flex® reagent cartridge LNTP - 00842768029929

N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10464338
In Commercial Distribution

  • 00842768029929 ()
  • 00630414005560 ()
RF723

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP - 00842768029912

LOCI N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464526
In Commercial Distribution

  • 00842768029912 ()
  • 00630414005683 ()
RF623

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
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