In response to concerns relating to insufficient supply and availability of face masks, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for face masks use by members of the general public and health care personnel (HCP), as personal protective equipment (PPE),  during the Coronavirus Disease 2019 (COVID-19) pandemic.

Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE) or hand sanitizers?

Are you considering shipping food products, medical devices, drug products or cosmetics to the United States?

The FDA oversees more than 36.9 million shipments of regulated products from over 150 countries to 130,000 U.S. importers. These products are manufactured, processed, or packaged at more than 300,000 foreign facilities.

The registration of your facility or establishment with the FDA is required, and ITB HOLDINGS LLC is ready to assist.

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■ Domestic and foreign companies are required to have a DUNS (Data Universal Numbering System) Number issued by Dun & Bradstreet Inc to all types of business organizations including sole proprietorships, corporations, partnerships, non-profits, and government entities.

$99.00 for Food Facility Registration. Click on link below.

    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings.
    • U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.
    • FDA issued an EUA for the first over-the-counter, at-home, rapid diagnostic test for COVID-19. The Ellume COVID-19 Home Test, authorized for individuals 2 years old and older, with or without symptoms, detects proteins of the SARS-CoV-2 virus from a nasal swab sample. It can be used completely at home without a prescription and requires the use of a compatible smartphone and a downloadable app to provide testing instructions and deliver results in as little as 20 minutes.
    • FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test.
    As with any type of personal protective equipment (PPE), the key to proper selection and use of gowns and coveralls, is to understand the hazards and the risk of exposure.
    Food Facilities
    Medical Devices (PPEs)
    OTC Drugs (Hand Sanitizers)