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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 Class Implantable

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Fastep COVID-19 Antigen Home Test 5 Test Per Pack
Azure Biotech, Inc.
COV-S23010H5
In Commercial Distribution

  • 00810022630372 ()


  • SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Case of 5 for Mojo First Responder-Intermediate Your Mojo Medical Bag is equipped with MARCH Medical Gear featuring simple treatment icons and color-coding below: MASSIVE HEMORRAHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898330305010 ()
83-303-05

  • First aid kit, medicated
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-5-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712516 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Rapid-Seal Antibacterial Stops Bleeding Kit, 15 pieces: 5 - Rapid-Seal Antibacterial Wound Gel 0.068 FL OZ (2ml); 5 Flexible Fabric Adhesive Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 5 Gauze Pads 2 IN x 2 IN (50 mm x 50 mm)
Aso LLC
00017276239393
In Commercial Distribution

  • 00017276239393 ()
  • 20017276239397 ()
X003SMVC0F

  • First aid kit, medicated
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
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-5
In Commercial Distribution

  • 10816862024682 ()
  • 00816862024685 ()
  • 00816862024678 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Retro Refill Pack For Medium Metal General Business Cabinet - Contains: Burn Dressing, 4" x 4"; Cold Pack, 4" x 5"; First Aid Tape, 0.5" x 5 yd and Gauze Roll, 2" x 4 yd; Hand Sanitizer Packets, 10 ct: Sterile Eyepads 2 ct, 1 oz Eyewash, and 0.5" x 5 yd Tape Roll; Trauma Pads, 5" x 9", 2 ct; Triangular Bandage and CPR Face Shield.
Acme United Corporation
90745
In Commercial Distribution

  • 00092265907453 ()
90745

  • First aid kit, medicated
COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
In Commercial Distribution



  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
In Commercial Distribution

  • 00197644204359 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Minor Wound Care Kit, Unit Box - Contains: 2 Antiseptic Wipes; First Aid Tape, 1/2" x 5 yd; Conforming Gauze Roll, 2"; 2 Nitrile Exam Gloves; Trauma Pad, 5" x 9".
Acme United Corporation
750012
In Commercial Distribution

  • 00092265750127 ()
750012

  • First aid kit, medicated
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