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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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Status™ COVID-19/Flu A&B Antigen test kit, 25 tests
PRINCETON BIOMEDITECH CORPORATION
BSP-511-25
In Commercial Distribution

  • 10743816001553 ()
BSP-511-25

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
The illumigene Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The illumigene Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the illumigene Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.
MERIDIAN BIOSCIENCE, INC.
280150
Not in Commercial Distribution

  • 00840733101335 ()
280150

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.
MERIDIAN BIOSCIENCE, INC.
480150
In Commercial Distribution

  • 00840733102264 ()
480150

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia™ Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia™ Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479910
In Commercial Distribution

  • 00840733102127 ()
479910

  • Streptococcus mutans group antigen IVD, calibrator
DE BURNISHER DILLY A/ 21B A
NORDENT MANUFACTURING INC
BRDILLYA-21BA
In Commercial Distribution

  • 00840018628380 ()


  • Manual dental burnisher, reusable
BURNISHER DILLY A SIDE, 29T A
NORDENT MANUFACTURING INC
REBRDYTA-29TA
In Commercial Distribution

  • 00840018637061 ()


  • Manual dental burnisher, reusable
10XX2 + a BUP & A OXY strip
AMERICAN BIO MEDICA CORPORATION
10-10SPX2-339
In Commercial Distribution

  • 10694644200253 ()
  • 10694644250258 ()
10-10SPX2-339

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Root elevator "Cogswell" # A H-Type A
devemed GmbH
02-720-63
In Commercial Distribution

  • 04061644043248 ()


  • Dental elevator, tooth/root
content: - carrying bag A/N100503 - USB cable A/N100089 - ABR electrodes A/N100468 - NavPRO One A/N100360-NPO - Electrode trunk cable A/N100881 - electrode lead cable A/N100891-1 - Heaphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - Bone Conductor B71 A/N100344 - Gooseneck Microphone A/N100779 - FW ABR 100337 - FW eABR A/N100929 - FW ASSR A/N100465 - FW ECochG A/N100464 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMPDOAE A/N100536 - FW DPHiRES A/N100537 - FW PTA3 A/N 100114 - FW High Frequency A/N100454 - FW Magic A/N100112 - FW Labelprinter A/N100414 - FW Mira PC- Software A/N100116 - Accessory Box Combo A/N100261 - Power Supply US Sentiero Advanced A/N100268-US - User Manual A/N100904-EN-BL
PATH medical GmbH
100340-BLP1
Not in Commercial Distribution

  • 04260223143366 ()


  • Evoked-potential audiometer
A 3cc transducer connected with a 48" & a 12" Pressure Tubings
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682003
In Commercial Distribution

  • 50886333620031 ()
  • 00886333620036 ()

  • 3cc Transducer
682003

  • Invasive-pressure external transducer, single-use
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