Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Allergen And Vaccine Delivery Needles

FDA product code SCL · 25 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5570
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-12-30 – 2026-01-30

An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.

↑