FDA product code SCL

Allergen And Vaccine Delivery Needles

General Hospital·Class 2·21 CFR 880.5570
US regulatory classifications
US Product Code (FDA)
SCL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5570
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

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.

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About this record

Allergen And Vaccine Delivery Needles is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.