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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Approved Products

The following products are regulated as Biologics License Applications (BLAs):  Fractionated Plasma Products (Alpha-1-Proteinase Inhibitor, Antihemophilic Factor, Antithrombin, C1 Esterase Inhibitor, Coagulation Factors, Fibrin, Fibrinogen, Immune Globulins, Protein C, Thrombin) and Blood Donor Screening Tests for Infectious Diseases and Blood Grouping and Phenotyping.

The following products are regulated as New Drug Applications (NDAS): Solutions used in the collection of blood and plasma donations.

The following products are regulated as Premarket Approvals (PMAs): Devices associated with blood donor testing.

The following products are regulated as 510(k)s: Devices used by the blood banking industry including blood establishment computer software, transfer devices, collection systems, separators, culture bottles, fluid warmers, etc.

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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