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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The “COVID-19 IgM/IgG Rapid Test” is offered for sale and distributed in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from FDA.

Passage 2

Your product is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because statements on your website represent that the “COVID-19 IgM/IgG Rapid Test” is “FDA-approved.”