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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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Nova 10/10+ Analyzer w/ Printer /Dilutor
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539644 ()
  • 00385480539647 ()
53964

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 TUBING HARNESS WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146180 ()
14618

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 W/R PUMP TUBE WITHOUT DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131988 ()
13198

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 W/R PUMP TUBE WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131971 ()
13197

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
No Description
BIOTRONIK SE & Co. KG
394500
In Commercial Distribution

  • 04035479131609 ()
394500

  • Cardiac pulse generator analyser cable, single-use
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 08055182872367 ()
  • 08055182872343 ()
  • 18055182872364 ()
$92070-10

  • Plazomicin minimum inhibitory concentration (MIC) IVD
No Description
SCIMEDX CORPORATION
I-EBV03X
In Commercial Distribution

  • 00813545025618 ()
I-EBV03X

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator
Convenience kit containing Formalin, C&S and Clean Vials for stool collection.
MEDICAL CHEMICAL CORPORATION
891-20
In Commercial Distribution

  • M445891200 ()
  • M445891201 ()
891-20

  • 10% Neutral buffered formalin IVD
  • Carey-Blair transport medium IVD
  • General specimen receptacle transport container
This is a medical device.
KaVo Dental GmbH
1.003.6977
In Commercial Distribution

  • EKAV100369770 ()
10 E

  • Dental power tool system handpiece, line-powered
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