Regulatory Documents

ISO Certificates  |  SDS  |  Instructions for Use |
Certificates of Analysis  |  Declarations of Conformity  | 
Industry Specific

ISO CERTIFICATES

Heidelberg, Germany

Sparks, MD, USA

• ISO 13485 Certificate
• ISO 9001 Certificate

Le Pont-de-Claix, France

• ISO 9001 Certificate

Québec, Canada

• ISO 13485 Certificate

Temse, Belgium

• ISO 9001 Certificate

Burlington, North Carolina, USA

• ISO 13485 Certificate

SDS

• Safety Data Sheet (SDS) Online

INSTRUCTIONS FOR USE

Note : For any previous versions, please contact your local BD representatives.

List of Instructions for Use sorted by catalog number:

• Bulgarian
• Croatian 
• Czech
• Danish
• English
• Estonian
• French
• German 
• Greek
• Hungarian
• Italian
• Kazakh
• Lithuanian
• Norwegian
• Polish
• Portuguese
• Romanian
• Russian
• Serbian
• Slovak
• Spanish
• Swedish
• Turkish

• General Instructions For Use
• 212116 - BD™ BBL™ Oxi/Ferm™ Tube II, Biocode Manual
• 212117 - BD™ BBL™ Enterotube™ II, Interpretation Guide

CERTIFICATES OF ANALYSIS (CoA)

• Certificates of Analysis - BD Microtrol™ only
• Certificates of Analysis - Others

DECLARATIONS  OF CONFORMITY (DofC)

• List of Declarations of Conformity sorted by catalog number

INDUSTRY SPECIFIC

• Customer Regulatory Support Information - please visit here

Statements :

• Animal Origin Position Statement
• Intended use of products labeled "For Laboratory Use"
• Storage and transport of Antigen, Antiserum, coagulase & FA products Statement

Instructions For Use :

Dehydrated Culture Media

• DCM
• Additives  

Media and Ingredients

• Meat peptones and Media

• Chemically defined Products

• Media for Media Fill

• Others

Aseptic plated media

• 90 mm plates
• Biplates
• Special Format
• Quad plates
• Hycheck™ Hygiene Contact Slides
• Accessories
• Aseptic Contact Plates

 

Sterile plated media

• Aseptic Trypticase™ Soy Agar and Sabouraud Dextrose Agar Plates
• Sterile pack plated media
• Isolator pack plated media
• Isolator Pack XT plated media
• Sterile Pack Swab

 

Bottled media

• Bottled media - Agar in bottles
• Bottled media - Rinsing Fluids
• Bottled media - Broth in bottles / Sterility test broth
• Bottled media - Broth in bottles / Others

 

Tubed media

• Saline solution
• Sterility Test
• Other tubed media

 

Gas generating systems

 

 

Stains and reagents

• Gram Stain (Kits)
• Stains and Indicators
• Droppers
• Reagents, buffers and enzymes

 

Identification and quality control products

• BBL™ Crystal™ Identification Systems
• Enterotube™ II and Oxi/Ferm™ Tube II
• BBL Dryslide™
• BD Phoenix™ Instrument
• BD Phoenix™ Reagents
• BD Microtrol™ Quality Control Organisms

 

EP/USP TSM Media

• Test for E.coli
• Test for Bile Tolerant Gram Negative Bacteria
• Test for Salmonella Spp
• Test for Pseudomonas aeruginosa
• Test for Staphylococcus aureus
• Test for Clostridia
• Test for Candida albicans
• Buffers and Solutions

 

Automated Sterility Testing

• BD BACTEC™ FX Instrument
• BD BACTEC™ FX Consumables

 

Automated Plate Streaking

• BD™ Innova Automated Microbiology Specimen Processor

Other Documents :

• List of Products with Certificate of Suitability (COS) 
  Note : For additional information, please contact your local BD representatives.

• Harmonized Microbiological Examination of Nonsterile Products with BD™ Culture Media (USP /EP)