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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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Urisys 2400 Cassette - 04015630004652

No Description
Roche Diagnostics GmbH
3012557061
In Commercial Distribution

  • 04015630004652 ()
3012557061

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

TECO DIAGNOSTICS - 10673486000146

URS-1B-100 GENERIC
TECO DIAGNOSTICS
URS-1B-100 GENERIC
In Commercial Distribution

  • 10673486000146 ()
URS-1B-100G

  • Urine blood IVD, kit, rapid colorimetric, clinical

TECO DIAGNOSTICS - 10673486000139

URS-1B-100 BOTTLE ONLY
TECO DIAGNOSTICS
URS-1B-100 BOTTLE
In Commercial Distribution

  • 10673486000139 ()
URS-1B-100B

  • Urine blood IVD, kit, rapid colorimetric, clinical

TECO DIAGNOSTICS - 10673486000122

URS-1B-100 FINISHED KIT
TECO DIAGNOSTICS
URS-1B-100
In Commercial Distribution

  • 10673486000122 ()
URS-1B-100

  • Urine blood IVD, kit, rapid colorimetric, clinical

TECO DIAGNOSTICS - 10673486000085

URS-1B-50-01 FINISHED KIT
TECO DIAGNOSTICS
URS-1B-50-01 MUSTAFA
In Commercial Distribution

  • 10673486000085 ()
URS-1B-50-01

  • Urine blood IVD, kit, rapid colorimetric, clinical

MBT Sepsityper Kit US IVD - 04251204326182

Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA
Bruker Daltonik GmbH
1867565
In Commercial Distribution

  • 04251204326182 ()
1867565

  • Mass spectrometry analysis specimen preparation kit IVD

UniARM - 04589698450022

The UniARM is for use in holding medical devices such a endoscopes and retractors in surgery.
MITAKA KOHKI CO., LTD.
UA1
In Commercial Distribution

  • 04589698450022 ()


  • Surgical instrument assist arm system, power-adjusted

GLUC-HK - 05055273208764

The product is intended for the quantitative in vitro determination of Glucose in serum or urine.
RANDOX LABORATORIES LIMITED
GL8319
In Commercial Distribution

  • 05055273208764 ()
GL8319

  • Glucose IVD, reagent

Na - 05055273204698

This product is intended for the quantitative in vitro determination of Sodium in serum and plasma
RANDOX LABORATORIES LIMITED
NA3851
In Commercial Distribution

  • 05055273204698 ()
NA3851

  • Sodium (Na+) IVD, reagent

IgA - 05055273203899

The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA3895
Not in Commercial Distribution

  • 05055273203899 ()
IA3895

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
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