This product lot is supplied by Hardy Diagnostics in accordance with its quality management system, which complies with the U.S. Food and Drug Administration’s (FDA’s) Quality Systems Regulation (QSR) and current Good Manufacturing Practices (cGMP) contained in Title 21 Part 820 of the Code of Federal Regulations (CFR).
The company’s manufacturing establishments are registered, and its medical devices are listed with the FDA. Hardy Diagnostics’ quality management system is certified to ISO 13485 for medical devices.
Representative samples of this lot were tested and found to meet the specifications listed on this certificate and published in “Technical Documents and IFUs” under the “Technical Support” menu item located at www.HardyDiagnostics.com, where applicable. In addition, this lot conforms to the quality control standards listed in the reference document, where indicated. End users of commercially prepared culture media and reagents should perform QC testing in accordance with applicable government regulatory agencies and in compliance with accreditation requirements. Hardy Diagnostics recommends end user to check for signs of contamination and deterioration and, if dictated by laboratory quality control procedures or regulation, perform quality control testing to
demonstrate a positive reaction and/or a negative reaction, if applicable.
Acceptable microbial load (as described in the “Test for Microbial Load” section of the Finished Product Quality Control) was verified at the time of release. Finished Product Quality Control is published in “Technical Documents and IFUs” under the “Technical Support” menu located at ww.HardyDiagnostics.com.
Ingredient Origin
All ingredients of animal origin in this lot have been sourced from Bovine Spongiform Encephalopathy- (BSE-) free and Transmissible Spongiform Encephalopathy- (TSE-) free countries as identified by the United States Department of Agriculture (USDA). This product complies with 9 CFR 94.18 “Restrictions on importation of meat and edible products from ruminants due to bovine spongiform encephalopathy.”
Manufacturing Facility
Hardy Diagnostics maintains manufacturing facilities in both Santa Maria, California and Springboro, Ohio. Each lot’s manufacturing location can be determined from the lot number. If the lot number is preceded by the letter “H,”
STORAGE AND SHELF LIFE
Storage: Upon receipt; store plates at 2-8°C., and store tubes and bottled media at 2-30°C. Products should not be used if there are any signs of contamination, deterioration (shrinking, cracking, or discoloration), or if the expiration date has passed. Product is light and temperature sensitive; protect from light, excessive heat, moisture, and freezing.