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Diagnostic Systems - Regulatory

Regulatory Documents


Customer Regulatory Support Information

Customer Regulatory Support Information

For questions on topics not covered in the list below, please contact us here.

  • Animal Origin Raw Materials- BD Diagnostics - Diagnostic Systems 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 Diagnostic Systems, please contact us here.

For a summary of the Diagnostic Systems policy concerning animal origin and animal free products, please refer to the BD Diagnostics - Diagnostic Systems Animal Origin Position Statement located here.

  • Allergens- BD Diagnostics - Diagnostic Systems 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 SDS (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 Diagnostics - Diagnostic Systems Animal Origin Position Statement is located here. This document summarizes the Diagnostic Systems policy concerning animal origin and animal free products.

For additional information about allergens, or to request a signed statement regarding allergens, please contact us here.

  • BSE/TSE Statement- BD Diagnostics - Diagnostic Systems 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 us here.

  • CartagenaProtocol- BD Diagnostics - Diagnostic Systems products 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 Diagnostic Systems products, please contact us here.
  • Certificates of Analysis/Origin - BD Certificates of Analysis are available 24/7 at regdocs.bd.com. 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. Certificates of origin which are not mentioned on certificates of analysis are available upon request, please contact us here.
  • Change Notification- Under our Standard Change Notification Policy, BD Diagnostics - Diagnostic Systems 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, Diagnostic Systems and Advanced Bioprocessing have 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 us here.

  • Customer Audits- BD Diagnostics - Diagnostic Systems offers 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.
  • Customer Questionnaires- BD Diagnostics - Diagnostic Systems often receives requests from customers to complete their supplier questionnaires. These questionnaires may be sent directly to this address.
  • GMP (Good Manufacturing Practices)- BD Diagnostics - Diagnostic Systems are manufactured in ISO 9001:2008 Registered facilities. In addition, Diagnostic Systems facilities are registered with the United States Food and Drug Administration (FDA), are regulated by the FDA's Quality System Regulations (QSRs), and are also ISO 13485:2003 Registered. Products are manufactured following our established procedures, current Good Manufacturing Practices (cGMPs) defined in 21 CFR Parts 820 or 210/211, and both ISO 9001:2008 and ISO 13485:2003 requirements. For additional information, or to request a signed statement regarding our manufacturing facilities, please contact us here.
  • GMO (Genetically Modified Organisms)- BD Diagnostics - Diagnostic Systems do 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.
  • Halal- BD Diagnostics - Diagnostic Systems 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 regdocs.bd.com.

For additional information, or to request a signed statement regarding Halal certification, please contact us via e-mail.  

  • Kosher- BD Diagnostics - Diagnostic Systems 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 regdocs.bd.com.

For additional information, or to request a signed statement regarding Kosher certification, please contact us via e-mail.  

  • Melamine- 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 Diagnostics - Diagnostic Systems products:

BD certifies that the compound melamine is not used by BD in the production of any Diagnostic Systems 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 us here.  

  • Pallet Requirements- 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 us here. 

  • Porcine Influenza- In light of porcine influenza concerns, and related requests for information about BD Diagnostics - Diagnostic Systems 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 us here. 

  • REACH- The production facilities for BD Diagnostics - Diagnostic Systems 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 here. 

  • Other- For questions on topics not covered in the list above, please contact us here.