Isoplate

Terumo BCT Ltd.🇺🇸 United States

FDA Page

Effective Date: Dec 4, 2018
Approval ID: 37932532-4fbf-4485-abe6-d2c9f9fc3b80
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] safely and effectively. See full prescribing information for ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F]. ISOPLATE SOLUTION Platelet Additive Solution [PAS-F] Sterile Fluid Polyolefin Bag Initial U.S. Approval: 2013

Quick Stats

Total Products1

Labelers2

Label Sections15

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.