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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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IMMULITE® Probe Wash Module - 00842768028410

For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385393
In Commercial Distribution

  • 00842768028410 ()
  • 00842768019760 ()
LPWS2

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

ADVIA 120/2120/2120i Vent Line Wash Kit - 00842768027307

ADVIA 120/2120/2120i Vent Line Wash Kit
Siemens Healthcare Diagnostics Inc.
11306492
In Commercial Distribution

  • 00630414287102 ()
  • 00842768027307 ()
11306492

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

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® Flex® reagent cartridge LIPL - 00842768025532

Lipase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10460277
In Commercial Distribution

  • 00842768025532 ()
  • 00630414005454 ()
DF56

  • Lipase IVD, kit, spectrophotometry

Atellica IM Herpes-2 IgG Quality Control - 00842768022838

Herpes-2 IgG (HSV2) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733034
In Commercial Distribution

  • 00842768022838 ()
10733034

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
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