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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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FREND COVID-19 total Ab - 08809317540924

The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Flowflex COVID-19 Antigen Home Test - 00682607660476

Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Acon Laboratories, Inc.
L031-125P5
In Commercial Distribution

  • 20682607660470 ()
  • 00682607660476 ()
  • 00682607002306 ()
660476

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Flowflex COVID-19 Antigen Home Test - 00682607660285

Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
Acon Laboratories, Inc.
L031-125N5
In Commercial Distribution

  • 20682607660289 ()
  • 00682607660285 ()
  • 00682607002306 ()
660285

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Flowflex COVID-19 Antigen Home Test - 00682607660278

Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
Acon Laboratories, Inc.
L031-125M5
In Commercial Distribution

  • 20682607660272 ()
  • 00682607660278 ()
  • 00682607002306 ()
660278

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Flowflex COVID-19 Antigen Home Test - 00682607660261

Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1)
Acon Laboratories, Inc.
L031-118B5
In Commercial Distribution

  • 10682607660268 ()
  • 00682607660261 ()
  • 20682607533262 ()
  • 20682607660265 ()
  • 00682607002306 ()
660261

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Flowflex Plus COVID-19 and Flu A/B Home Test - 00810107290002

1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Acon Laboratories, Inc.
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
In Commercial Distribution

  • 30810107290041 ()
  • 00810107290040 ()
  • 00810107290002 ()
  • 30810107290034 ()
  • 00810107290033 ()
  • 60810107290035 ()
  • 40810107290024 ()
  • 00810107290026 ()
  • 10810107290030 ()
  • 50810107290014 ()
  • 40810107290017 ()
  • 00810107290019 ()
  • 10810107290016 ()
  • 20810107290020 ()
  • 10810107290023 ()
  • 20810107290037 ()
  • 60810107290028 ()
  • 60810107290011 ()
  • 40810107290031 ()
  • 30810107290010 ()
  • 50810107290038 ()
  • 30810107290027 ()
  • 20810107290013 ()
  • 70810107290032 ()
  • 80810107290039 ()
  • 50810107290021 ()
  • 80810107290015 ()
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

Nano-Check TM COVID-19 Antigen Test - 00895160002786

An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002783 ()
  • 00895160002786 ()
  • 20895160002780 ()
MD-8147-20T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

UroShield 3.0 Driver - 07290103420277

The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections).
NANOVIBRONIX INC.
3.0
In Commercial Distribution

  • 07290103420277 ()
10-800-0003

  • Urinary catheter ultrasonic bacterial adhesion inhibition system

Traveler Kit (EPMK) - 00850018201599

The Emergency Preparedness Medical Kit - Traveler Kit is small and lightweight yet still packed full of necessary first aid supplies to treat a variety of issues to include dehydration, scrapes, cuts, and over-the-counter medications for multiple ailments.
Altitude Technologies Inc.
01423RD
In Commercial Distribution

  • 00850018201599 ()
01423RD

  • First aid kit, medicated
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