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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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No Description
Orasure Technologies, Inc.
1001-0320
In Commercial Distribution

  • 20608337000065 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
190
Not in Commercial Distribution

  • 00742860001901 ()
  • 10742860001908 ()
190

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Influenza A & B Test NASOPHARYNGEAL WASH/ASPIRATE KIT
MCKESSON MEDICAL-SURGICAL INC.
181-36026
In Commercial Distribution

  • 20612479226795 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution

  • 00608337000054 ()


  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "A" is labeled for connections to electrodes 1-64.
NEURALYNX, INC.
-A
In Commercial Distribution

  • 00850011306369 ()
31-0602-0032

  • Electrical-only medical device connection cable, reusable
The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection). The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose. See https://cleverculturesystems.com for further information.
Clever Culture Systems AG
A
In Commercial Distribution

  • 09354646000001 ()
AI-16001

  • Microbial culture plate imaging/analysis system IVD
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450008772 ()
  • 00884450008775 ()

  • Introducer French Size (F)-5F
  • Needle Gauge (G)-21G
  • Introducer Length (cm)-10 cm (4")
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
MAK505-PED

  • Vascular dilator, single-use
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