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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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GenBody COVID-19 Ag Home Test - 08800076700598

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-25
In Commercial Distribution

  • 08800076700765 ()
  • 08800076700598 ()
COVAGHT2-U-25

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

GenBody COVID-19 Ag - 08800076700482

Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAG025-NU
In Commercial Distribution

  • 08800076700499 ()
  • 08800076700482 ()
COVAG025-NU

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

GenBody COVID-19 Ag - 08800076700437

Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.
Genbody Inc.
COVAG025-U
In Commercial Distribution

  • 08800076700437 ()
  • 08800076700475 ()
COVAG025-U

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

GenBody COVID-19 Ag Home Test - 08800076700222

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-2
In Commercial Distribution

  • 08800076700741 ()
  • 08800076700222 ()
COVAGHT2-U-02

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

EliA CoV Positive Control C1 250 - 07333066021232

EliA CoV Positive Control C1 250
Phadia AB
83-0042-11
In Commercial Distribution

  • 07333066021263 ()
  • 07333066021232 ()
83-0042-11

  • Plasma protein IVD, control

Walgreens - 00311917212128

All-Purpose First Aid Kit, 150 pieces + 1 carrying case: 40 – Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 30 – Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 12 - Waterproof Bandages 3/4 IN x 2 IN (19 mm x 50 mm); 8 – Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 4 – Fabric Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 3 – Fabric Knuckle Bandages 1 1/2 IN x 3 IN (38 mm x 76 mm); 2 – Nitrile Exam Gloves; 2 – Wooden Finger Splints; 1 – Paper Tape 1 IN x 5 YD (25 mm x 4.5 m); 1 – Metal Tweezers; 1 – Cold Pack; 1 – First Aid Guide; 14 – Alcohol Prep Pads 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 6 – Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 4 – Acetaminophen Tablets (2 per packet); 4 – Allergy Caplets (1 per packet); 3 – Triple Antibiotic Ointments 1/32 OZ (0.9 g); 2 - Hydrocortisone Cream 1/32 OZ (0.9 g); 1 – First Aid & Burn Cream 1/32 OZ (0.9 g); 6 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 3 – Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 2 – Gauze Pads 4 IN x 4 IN (101 mm x 101 mm).
WALGREEN CO.
547526
Not in Commercial Distribution

  • 20311917212122 ()
  • 00311917212128 ()


  • First aid kit, medicated

First Aid Only - 00092265909280

10 Person Restaurant First Aid Kit - Contains: Antiseptic Wipes (10); Blue Metal Detectable Fabric Bandages, 1" x 3" (16); Burn Dressing, 4" x 4"; Cold Pack, 4" x 5"; Conforming Gauze Roll, 2"; CPR Face Shield; Eyewash, 1 oz; First Aid Guide; First Aid Tape, 1/2" x 5 yd; First Aid/Burn Cream Packets (10);Hand Sanitizer Packets (6); Nitrile Exam Gloves (4); Scissors; Sterile Eye Pads (2); Sterile Gauze Pads, 3" x 3" (2); Trauma Pads, 5" x 9" (2); Triangular Bandage, 40" x 40" x 56"; Triple Antibiotic Ointment Packets (10).
Acme United Corporation
90928
In Commercial Distribution

  • 00092265909280 ()
90928

  • First aid kit, medicated

First Aid Only - 00092265907828

10 Person Bulk First Aid Kit Refill - Contains: Adhesive Plastic Bandages, 1" x 3" (16); Antiseptic Wipes (10); Burn Dressing, 4" x 4"; Cold Pack, 4" x 5"; Conforming Gauze Roll, 2"; CPR Face Shield; Eyewash, 1oz bottle; First Aid Guide; First Aid Tape, 1/2" x 5yd; First Aid/Burn Cream Packets (10); Hand Sanitizer Packets (6); Nitrile Exam Gloves (4); Scissors; Sterile Eye Pads (2); Sterile Gauze Pads, 3" x 3" (2); Trauma Pads, 5" x 9" (2); Triangular Bandage, 40" x 40" x 56"; Triple Antibiotic Ointment Packets (10).
Acme United Corporation
90782
In Commercial Distribution

  • 00092265907828 ()
90782

  • First aid kit, medicated

BE SMART GET PREPARED - 00020424020262

Happy Hiker On the Go First Aid Kit 65 pieces by Be Smart Get Prepared – Camping, Hiking, Running, Boating, Fishing, Outdoor - (1) Silvex Wound Gel 0.18 oz; (6) Antiseptic Wipes; (3) Sting Relief Wipes; (2) Antibiotic Ointments 0.03 oz; (2) Burn Creams 0.03 oz; (15) Sheer Bandages 3/4 in x 3 in; (14) Assorted Blister Pads 1 pack; (10) Sheer Bandages 3/8 in x 1 1/2 in; (5) Butterfly Closures; (3) Waterproof Bandages 1 in x 3 in; (2) Sunscreens 0.05 oz; (2) Insect Repellents 0.03 oz
TOTAL RESOURCES INTERNATIONAL INC.
10OUT02026REV5
In Commercial Distribution

  • 00020424020262 ()


  • First aid kit, medicated

First Aid Only - 00092265905800

50 Person Large Plastic SmartCompliance First Aid Cabinet - Contains: Adhesive Fabric Bandages, 1" x 3", 25ct; Adhesive Plastic Bandages, 0.75" x 3", 25ct; Alcohol Pads 20ct; Antibiotic Ointment Packets, 10ct; Antiseptic Wipes 20ct; Burn Dressing, 4" x 4"; Castile Soap Towelettes, 10ct; Cold Pack, 4" x 5"; CPR Face Shield and 2 Nitrile Exam Gloves; Elastic Bandage Wrap, 2" x 5 yd; Fingertip Fabric Bandages, 10ct; First Aid Guide; First Aid Tape, 0.5" x 5yd and Gauze Roll, 2 x 4yd; First Aid/Burn Cream Packets, 10ct; Hand Sanitizer Packets, 10ct; Moleskin (Blister Prevention), 2" x 2", 10ct; Nitrile Exam Gloves, 4ct; Patch Plastic Bandages, 1.5" x 1.5", 10ct; Scissors; Sterile Eyepads 2 ct, 1oz Eyewash, and 0.5" x 5 yd Tape Roll; Sterile Gauze Pads, 2" x 2", 10ct; Sterile Gauze Pads, 3" x 3", 10ct; Trauma Pads, 5" x 9", 2ct; Triangular Bandage, 40" x 40" x 56"; Tweezers.
Acme United Corporation
90580
In Commercial Distribution

  • 00092265905800 ()
90580

  • First aid kit, medicated
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