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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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MININEPH Sample Diluent Pack - 05051700011501

No Description
THE BINDING SITE GROUP LIMITED
ZK502.R
Not in Commercial Distribution

  • 05051700011501 ()


  • Buffered sample diluent IVD, manual

MININEPH Reagent Accessory Pack - 05051700011495

No Description
THE BINDING SITE GROUP LIMITED
ZK500.R
Not in Commercial Distribution

  • 05051700011495 ()


  • Buffered sample diluent IVD, manual

LCO2-2 - 05055273213959

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD8357
In Commercial Distribution

  • 05055273213959 ()
CD8357

  • Bicarbonate (HCO3-) IVD, reagent

LCO2-2 - 05055273208375

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD4006
In Commercial Distribution

  • 05055273208375 ()
CD4006

  • Bicarbonate (HCO3-) IVD, reagent

Atellica CH UN_c - 00630414596471

Urea Nitrogen (UN_c) Atellica CH - RGT 6240T
Siemens Healthcare Diagnostics Inc.
11097593
In Commercial Distribution

  • 00630414596471 ()
11097593

  • Urea IVD, kit, enzyme spectrophotometry

Atellica CH Sal - 00630414595887

Salicylate (Sal) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097523
In Commercial Distribution

  • 00630414595887 ()
11097523

  • Salicylate IVD, kit, enzyme spectrophotometry

ADVIA® Chemistry UN_c Urea Nitrogen Reagents, Concentrated - 00630414553214

Urea Nitrogen - ADVIA Chem. - Conc. RGT - 4x2360 tests
Siemens Healthcare Diagnostics Inc.
10283349
In Commercial Distribution

  • 00630414553214 ()
6860558

  • Urea IVD, kit, enzyme spectrophotometry

ADVIA® Chemistry UN Urea Nitrogen Reagents - 00630414517513

Urea Nitrogen - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10309051
In Commercial Distribution

  • 00630414517513 ()
3040257

  • Urea IVD, kit, enzyme spectrophotometry

ADVIA® Chemistry CKNAC Creatine Kinase Reagents - 00630414508337

CK - ADVIA Chem. - RGT - 7x140 tests
Siemens Healthcare Diagnostics Inc.
10309494
Not in Commercial Distribution

  • 00630414508337 ()
  • 00630414003061 ()
7498541

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

ADVIA® Chemistry SAL Salicylate Reagents - 00630414498959

Salicylate - ADVIA Chem. - RGT - 4x150 tests
Siemens Healthcare Diagnostics Inc.
10327382
In Commercial Distribution

  • 00630414498959 ()
7989456

  • Salicylate IVD, kit, enzyme spectrophotometry
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