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Immunoglobulin G (Igg) Infusion System

FDA product code PKP · 6 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5725
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-12-01 – 2025-12-22

An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.

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