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QLFClass II

On-Body Injector

21 CFR 880.5860 / General Hospital
FDA source (opens on fda.gov)

QLF is the FDA product code for On-Body Injector, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QLF
Device name
On-Body Injector
FDA definition
An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs.
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code