Recall Class: Class I Date Recall Initiated: December 30, 2008 Products: Product #1: AccuProbe Group B Streptococcus Culture Identification TestProduct #2: AccuProbe Mycobacterium Tuberculosis Complex Culture Identification TestProduct #3: AccuProbe Mycobacterium Avium Complex Culture Identification Test These products were manufactured from September 24, 2008 through October 31, 2008 and distributed from October, 2008 through December,…
Consumer Information on: LAP-BAND Adjustable Gastric Banding System
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: LAP-BAND® Adjustable Gastric Banding SystemPMA…
Guidance for Industry and FDA Staff
Document issued on: March 23, 2011 For questions regarding this document contact Donna Roscoe at 301-796-6183 ([email protected]), or Marina Kondratovich at 301-796-6036 ([email protected]). U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of In Vitro Diagnostic Device Evaluation and SafetyDivision of Immunology and Hematology Devices Preface Public Comment You…
Black Ant: Undeclared Drug Ingredient
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Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test: Class I Recall
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American Regent Injectable Products: Recall
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Additions/Deletions for Prescription and OTC Drug Product Lists
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Letter to Industry about Import Entry Review Process
Dear Official Correspondent/United States Agent, The United States Food and Drug Administration (USFDA), Center for Devices and Radiological Health (CDRH), is increasingly concerned with the number of imported medical devices that do not have sufficient entry data to allow the USFDA to make a prompt admissibility decision at the port of entry into the United…
Consumer Information on: Elana Surgical KitHUD
FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Elana Surgical KitHUDManufacturer: Elana bv Address: Yalelaan 44, 3584…