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skin-test diagnostic product

Defined in 1 place of the United States Code.

The term “skin-test diagnostic product”—

(A) means a product—

(i) for prick, scratch, intradermal, or subcutaneous administration;

(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;

(iii) not intended to be a preventive or therapeutic intervention; and

(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—

(I) an allergy to an antimicrobial agent;

(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or

(III) infection with fungal or mycobacterial pathogens; and

(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).

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