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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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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 Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
NANO-DITECH CORPORATION
MD8151E
In Commercial Distribution

  • 10895160002844 ()
  • 00895160002847 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
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
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
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
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
content: - carrying bag A/N100503 - USB Cable A/N100418 - AuDX PRO Flex A/N100434-AUPF - Probe EP-TY A/N100188-US - Insert Earphone Bio- Logic A/N100860-BL - Bone Conductor B71 A/N100344 - Gooseneck Microphone A/N100779 - FW Reflex & Tymp Class1 A/N100561 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMDPOAE A/N100536 - FW DPHiRES A/N100537 - FW Mira PC- Software A/N100116 - FW PTA3 A/N100114 - FW High Frequency A/N100454 - FW Magic A/N100112 - FW Labelprinter A/N100414 - Accessory Box Combo A/N100261 - Power Supply Senti/Sentiero Desktop US A/N100524 - User Manual A/N100904-EN-BL - Test Cavity Tymp A/N100549
PATH medical GmbH
100497-BLP1
Not in Commercial Distribution

  • 04260223143359 ()


  • Evoked-potential audiometer
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