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FDA Certificate.VR6568.MR6532
1 /2Pages

FDA Certificate.VR6568.MR6532

FDA Certificate.VR6568.MR6532
1 /2Pages

Catalog excerpts

FDA Certificate.VR6568.MR6532-1

FDA U.S. FOOD & DRUG ADMINISTRATION U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov CERTIFICATE TO FOREIGN GOVERNMENT In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug Administration (FDA) certifies the following information concerning the product(s) to be exported listed below: Name of Product(s) Name of Manufacturer/Distributor, Address See Attached List See Attached List The product(s) described above (and the manufacturing/distribution site(s) which produces/distributes it) is subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. It is certified that the above device product(s) may be marketed in, and legally exported from, the United States of America at this time. While the manufacturing plant(s) in which the device product(s) is produced is subject to inspection, FDA does not routinely inspect manufacturing firms that only make Class 1 medical devices. However, the firm has certified that it is currently operating in substantial compliance with current good manufacturing practice requirements for the device product(s) listed above. CDR Cesar A. Perez, PhD, Director DRP2: Division of Establishment Support Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food and Drug Administration, DHHS This certificate is valid from February 18, 2021 to February 17, 2023.

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FDA Certificate.VR6568.MR6532-2

FDA U.S. FOOD & DRUG ADMINISTRATION fNTER FOR DEVICES AND RADIOLOGICAL HEALTH U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Certificate No. 5908-2-2021Certificate to Foreign Government - Name of Product(s) Attachment Page 1 of 1 Name of Corporate Headquarters Biomiga, Inc. 10637 Roselle Street, Suite C San Diego, CAUSA 92121 10637 Roselle Street, Suite C San Diego, CAUSA 92121 Viral RNA Extraction from Respiratory Specimens, VR6568-02, 250 Preps MgPure Viral RNA Purification Kit, MR6532-02, 20x96 Preps -------------------------------END OF PRODUCT...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.