skin-test diagnostic product

(12) 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).


21 USC § 379g(12)

Scoping language

For purposes of this subpart
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