BD Life Sciences - Integrated Diagnostic Solutions provides information about animal origin materials used in the manufacture of our finished products, using Certificates of Analysis available online here.
For additional information regarding the animal or non-animal origin of BD Life Sciences - Integrated Diagnostic Solutions, please contact BD Technical Services at 800.638.8663 or via e-mail.
For a summary of the BD Life Sciences - Integrated Diagnostic Solutions policy concerning animal origin and animal free products, please refer to the BD Life Sciences - Integrated Diagnostic Solutions Animal Origin Position Statement located here.
BD Life Sciences - Integrated Diagnostic Solutions products are not intended to be used as food, as ingredients in food, or as direct components/constituents of ingredients used in food. Therefore, these products do not fall under US or international food allergen regulations. For these products, neither incoming ingredients nor the finished products themselves are tested for the presence of allergens. The information we make readily available to customers concerning the material used in our products is as follows:
For chemical origin ingredients classified as allergens, product-specific chemical allergen information is included on the respective MSDS (material safety data sheet) which is available here.
For animal origin materials used in the manufacture of these products:
- Batch-specific animal origin information is included on the BD Certificate of Analysis, which is available here.
- The BD Life Sciences - Integrated Diagnostic Solutions Animal Origin Position Statement is located here. This document summarizes the BD Life Sciences - Integrated Diagnostic Solutions policy concerning animal origin and animal free products.
For additional information about allergens, or to request a signed statement regarding allergens, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions provides BSE/TSE Certificates (Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy) upon request. In the case of products for which BD has obtained a Certificate of Suitability for TSE from the European Directorate for the Quality of Medicine (EDQM), BD provides an authorized copy to customers with a regulatory need for this. In the case of products where such a Certificate of Suitability is not applicable, BD provides a BSE/TSE Certificate explaining how the product does not fall under the related requirements in chapter 5.2.8 of the European Pharmacopoeia.
For additional information about BSE/TSE Certificates, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions products and raw materials do not fall under the objective or scope of the Cartagena Protocol, since none of the products are or contain a living organism. For additional information, or to request a signed statement regarding the Cartagena Protocol and BD Life Sciences - Integrated Diagnostic Solutions products, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Certificates of Analysis are available 24/7 at www.bd.com/regdocs. Certificates of Analysis for products containing animal origin raw materials have lot-specific animal origin information included. Certificates of Analysis may be accessed by entering the BD product catalog number and lot number, and may be downloaded as Adobe PDF files.
Under our Standard Change Notification Policy, BD Life Sciences - Integrated Diagnostic Solutions notify all customers of certain changes to our products.
For customers who require notification of changes above and beyond the changes covered under the Standard Change Notification Policy, or by notification methods different from standard methods, BD Life Sciences - Integrated Diagnostic Solutions has developed the Automated Change Notification Program. This program is available for Difco™and BBL™ brand culture media products, e.g. Dehydrated Culture Media (including Tissue Culture Media), Prepared Plated Media, Prepared Tubed Media and Prepared Bottled Media, as well as certain miscellaneous laboratory reagents.
For additional information, or to request an enrollment for the Automated Change Notification Program, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions maintains a team of highly trained, dedicated, Service professionals to assist with technical questions or issues regarding our products. Once a complaint is received, our Quality professionals perform a thorough investigation and respond to the customer in a timely manner. To report a complaint about any of our products, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions offer on-site quality systems audits to customers who have a regulatory need for this. To request a quality systems audit, please contact your BD Sales Representative.
BD Life Sciences - Integrated Diagnostic Solutions often receive requests from customers to complete their supplier questionnaires.
For additional information, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions does not screen raw materials or finished products for GMO and do not have any raw material or finished product specifications that govern the use of GMO. The information BD provides about GMO, in response to customer requests concerning specific products, is based upon the GMO information we have received to date from our ingredient suppliers. For additional information regarding specific products, please contact us via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions uses a wide variety of animal and non-animal origin raw materials to formulate our various multipurpose, differential and/or selective culture media for use with thousands of different microorganisms.
BD has not sought Halal certification for any culture media products, as they are technical products that are intended for use by trained microbiologists, and are not intended for human consumption. This use-limitation is indicated on the labeling by the phrase "For Laboratory Use." However, certain culture media may meet specific animal origin requirements with regard to type of animal tissue used, country of origin for the specific tissues, etc. Batch-specific animal origin information is included on the BD Certificate of Analysis, which is available at www.bd.com/regdocs.
For additional information, or to request a signed statement regarding Halal certification, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions products are manufactured in ISO 13485:2016 Certified facilities, available here. Our products are registered with the United States Food and Drug Administration (FDA), and are regulated by the FDA's Quality System Regulations (QSRs). Our products are manufactured following our established procedures and current Good Manufacturing Practices (cGMPs) as defined in 21 CFR Part 820. For additional information, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions uses a wide variety of animal and non-animal origin raw materials to formulate our various multipurpose, differential and/or selective culture media for use with thousands of different microorganisms.
BD has not sought Kosher certification for any culture media products, as they are technical products that are intended for use by trained microbiologists, and are not intended for human consumption. This use-limitation is indicated on the labeling by the phrase "For Laboratory Use." However, certain culture media may meet specific animal origin requirements with regard to type of animal tissue used, country of origin for the specific tissues, etc. Batch-specific animal origin information is included on the BD Certificate of Analysis, which is available at www.bd.com/regdocs.
For additional information, or to request a signed statement regarding Kosher certification, please contact BD Technical Services at 800.638.8663 or via e-mail.
BD Life Sciences - Integrated Diagnostic Solutions Products - BD Certificates of Analysis (COAs), which can be accessed on www.bd.com/regdocs, provide information about the BD Manufacturing Site in the upper left corner of the BD COA. For BD Life Sciences - Integrated Diagnostic Solutions, the BD COA also provides information about the location of the Manufacturer, where that information differs from the Manufacturing Site shown in the header of the COA. The Manufacturer information is found in the text following the specifications section of the COA. For further clarification on the location of Manufacturer and the Manufacturing Site, please contact BD Technical Services at 800.638.8663 or via e-mail.
In response to the Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination, issued by the Food and Drug Administration in August 2009, BD makes the following statement regarding BD Life Sciences - Integrated Diagnostic Solutions products:
BD certifies that the compound melamine is not used by BD in the production of any BD Life Sciences - Integrated Diagnostic Solutions media products, and these products are not tested for the presence/absence of melamine.
For additional information, or to request a signed statement regarding melamine, please contact BD Technical Services at 800.638.8663 or via e-mail.
Material Safety Data Sheets for individual products are available here.
BD has received inquiries regarding the pallets that are used to ship BD products. BD has policies and procedures in place to control the safety of the pallets that are used by BD. For additional information, or to request a signed statement regarding the safety of BD pallets, please contact BD Technical Services at 800.638.8663 or via e-mail.
In light of porcine influenza concerns, and related requests for information about BD Life Sciences - Integrated Diagnostic Solutions porcine origin media products, a statement has been prepared addressing the health of the animals, countries of origin, and processing steps.
To request a signed statement regarding porcine influenza in relation to BD porcine origin media products, please contact Technical Services at 800.638.8663 or via e-mail
The production facilities for BD Life Sciences - Integrated Diagnostic Solutions products are working with the BD Global Product Stewardship Team to respond to questions regarding compliance of our products to the EU REACH regulation. For additional information please contact us via e-mail.
For questions on topics not covered in the list above, please contact BD Technical Services at 800.638.8663 or via e-mail.
