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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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Dimension Vista® LOCI 8 CAL - 00842768026492

LOCI 8 Calibrator, 2x5x2.5mL
Siemens Healthcare Diagnostics Inc.
10488192
In Commercial Distribution

  • 00842768026492 ()
KC646

  • Multiple human hormone IVD, calibrator

Dimension Vista® Total Testosterone Flex® Reagent Cartridge - 00842768026485

LOCI Total Testosterone Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10488399
In Commercial Distribution

  • 00842768026485 ()
  • 00630414016788 ()
K6465

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge PROG - 00842768026478

LOCI Progesterone Flex® reagent cartridge, 320 Tests
Siemens Healthcare Diagnostics Inc.
10461743
In Commercial Distribution

  • 00842768026478 ()
  • 00630414005461 ()
K6464

  • Progesterone IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge E2 - 00842768026461

LOCI Estradiol Flex® reagent cartridge, 320 Tests
Siemens Healthcare Diagnostics Inc.
10489099
In Commercial Distribution

  • 00842768026461 ()
  • 00630414005850 ()
K6463

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge PRL - 00842768026454

LOCI Prolactin Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488398
In Commercial Distribution

  • 00842768026454 ()
  • 00630414005812 ()
K6462

  • Prolactin IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge LH - 00842768026447

LOCI Luteinizing Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488534
In Commercial Distribution

  • 00842768026447 ()
  • 00630414005836 ()
K6461

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge FSH - 00842768026430

LOCI Follicle Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488533
In Commercial Distribution

  • 00842768026430 ()
  • 00630414005829 ()
K6460

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Dimension® NTP CAL - 00842768026324

LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10464529
In Commercial Distribution

  • 00842768026324 ()
RC623

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

Dimension® ENZ 1 CAL - 00842768026218

Enzyme I Calibrator, 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10284680
In Commercial Distribution

  • 00842768026218 ()
  • 00630414602004 ()
DC35

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension® Flex® reagent cartridge MBI - 00842768025556

Creatine Kinase MB Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464510
In Commercial Distribution

  • 00842768025556 ()
  • 00630414005638 ()
DF32

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry
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