Staphylococcus aureus subsp. aureus Rosenbach (ATCC® CRM-6538)

Strain Designations: FDA 209  /  Type Strain: no  /  Biosafety Level: 2

Permits And Restrictions

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Strain Designations FDA 209
Application
For use in testing and calibration in ISO 17025 accredited laboratories, to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation. ISO Guide 34:2009
Quality control strain for Biosynth products
This strain is recommended by ATCC for use in the tests described in military specification MIL G-13734B where only the taxon is specified.
Filtration Efficiency Testing
Efficacy testing
Inhibition testing
Media testing
Preparatory test control
Quality control strain
Testing
Testing antimicrobial agents
Testing antimicrobial handwashing formulations
Testing disinfectants
Testing sanitizers
Testing bactericides
Antimicrobial effectiveness testing RefU.S. Pharmacopeia General Chapters:<51> ANTIMICROBIAL EFFECTIVENESS TESTING. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011
Microbial enumeration tests RefU.S. Pharmacopeia General Chapters: <61> Microbial Examination of Nonsterile Products: Microbial Enumeration Tests. Rockville, MD USP34-NF29, 2011
Isolation
Human lesion
Type Strain no
Biosafety Level 2
Product Format freeze-dried
Intended Use

 

 

Certified Reference Material produced under an ISO Guide 34:2009 accredited process.

 

    ACLASS Accredited Reference Material Producer AR-1384

Preceptrol® no
Type Strain no
Comments Certificates of Analysis are available electronically at www.atcc.org, or by hardcopy upon request.

 

Certified Reference Material produced under an ISO Guide 34:2009 accredited process.

Medium ATCC® Medium 18: Trypticase Soy Agar/Broth
Growth Conditions
Temperature: 37°C
Atmosphere: Aerobic
Name of Depositor FDA
Chain of Custody
ATCC <-- FDA <-- AMC
Isolation
Human lesion
References

Connolly P, et al. The use of impedance for preservative efficacy testing of pharmaceuticals and cosmetic products. J. Appl. Bacteriol. 76: 68-74, 1994. PubMed: 8144407

ASTM International StandardTest Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces. West Conshohocken, PA

ASTM International Standard Test Method for Preservatives in Water-Containing Cosmetics. West Conshohocken, PA

AOAC International Germicidal and detergent sanitizing action of disinfectants. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 960.09.

AOAC International Bacteriostatic activity of laundry additive disinfectants. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 972.04.

British Pharmacopoeia Commission Test for sterility. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI A, 2003

British Pharmacopoeia Commission Tests for microbial contamination. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI B, 2003

British Pharmacopoeia Commission Efficacy of antimicrobial preservation. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI C, 2003

AATCC Antibacterial Finishes on Textile Materials: Assessment of. Research Triangle Park, NC:American Association of Textile Chemists and Colorists;AATCC Test Method 100-2004.

AATCC Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method. Research Triangle Park, NC:American Association of Textile Chemists and Colorists;AATCC Test Method 147-2004.

AATCC Antimicrobial Activity Assessment of Carpets. Research Triangle Park, NC:American Association of Textile Chemists and Colorists;AATCC Test Method 174-1998.

AOAC International Testing disinfectants against Staphylococcus aureus, phenol coefficient method. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 955.12.

AOAC International Chlorine (available) in disinfectants, germicidal equivalent concentration. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 955.16.

AOAC International Testing disinfectants against Staphylococcus aureus, hard surface carrier test method. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 991.48.

European Pharmacopoeia Commission Microbial contamination of products not required to comply with the test for sterility (total viable aerobic count). Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.6.12, 1997

European Pharmacopoeia Commission Microbial contamination of products not required to comply with the test for sterility (tests for specified micro-organisms). Nutritive and selective properties of the media and validity of the test for specified micro-organisms. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.6.13, 1997

European Pharmacopoeia Commission Efficacy of antimicrobial preservation. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 5.1.3, 1997

US General Services Administration Disinfectant, general purpose (liquid phenolic type). Washington, DC:US General Services Administration;Commercial Item Description A-A-1438A, 1997

US General Services Administration Disinfectant-detergent, general purpose (phenolic type). Washington, DC:US General Services Administration;Commercial Item Description A-A-1439A, 1998

US General Services Administration Disinfectant-detergent, general purpose (iodophor). Washington, DC:US General Services Administration;Commercial Item Description A-A-1440, 1981

US General Services Administration Disinfectant, general purpose (quaternary ammonium compound). Washington, DC:US General Services Administration;Commercial Item Description A-A-1441B, 2005

US General Services Administration Disinfectant-detergent, general purpose (quaternary ammonium compound). Washington, DC:US General Services Administration;Commercial Item Description A-A-1443A, 1998

U.S. Pharmacopeia General Chapters:<51> ANTIMICROBIAL EFFECTIVENESS TESTING. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011

U.S. Pharmacopeia General Chapters: <71> STERILITY TESTS. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011

U.S. Pharmacopeia Dietary Supplement Chapters: <2021> Microbial Enumeration Tests-Nutritional and Dietary Supplements. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

AOAC International Germicidal spray products as disinfectants. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 961.02.

Jones CB, Platt JH. Propofol composition containing edetate. US Patent 5,714,520 dated Feb 3 1998

Bowman FW, et al. Collaborative study of aerobic media for sterility testing by membrane filtration. J. Pharm. Sci. 60: 1087-1088, 1971. PubMed: 5000479

Testing Disinfectants against Staphylococcus aureus, Use-Dilution Methods. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 955.15.

Efficacy of Preservation on Non-Eye Area Water-Miscible Cosmetic and Toiletry Formaulations. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 998.10.

Microbial limit test. Tokyo, Japan:Japanese Pharmacopoeia;JP Jp14e.part I.35.

Microbial limit test for crude drugs. Tokyo, Japan:Japanese Pharmacopoeia;JP JP14e.part I.36.

Sterility test, Growth promotion test. Tokyo, Japan:Japanese Pharmacopoeia;JP JP14e.part I.54.

Preservatives-effectiveness test. Tokyo, Japan:Japanese Pharmacopoeia;JP JP14e.part II.12.

Disinfectants for Use on Hard Surfaces. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-1, 1982

Confimatory Efficacy Data Requirements. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-5, 1982

Carpet Sanitizers. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-8, 1981

Sanitizer Test or Inanimate Surfaces. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-10.

Air Sanitizers. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-11, 1980

Laundry Additives--Disinfection and Saitization. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-13, 1980

Laundry Additives- Residual Self-Sanitization. Washington, DC:Environmental Protection Agency;EPA EPA DIS/TSS-14, 1981

Microbiology of food and animal feeding stuffs--Guidelines on preparation and production of culture media-- Part 2: Practical guidelines on performance testing of culture media.. Geneva (Switzerland):International Organization for Standardization/ANSI;ISO ISO 11133-2:2003.

Ophthalmic optics--Contact lens care products--Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses. Geneva (Switzerland):International Organization for Standardization/ANSI;ISO ISO 14729:2001.

Ophthalmic optics--Contact lens care products--Antimicrobial preservative efficacy testing and guidance on determining discard date. Geneva (Switzerland):International Organization for Standardization/ANSI;ISO ISO 14730:2000.

Chemical disinfectants and antiseptics --- Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas --- Test method and requirements (phase 2, step 1). London, UK:British Standards Institution;British Standard BS EN 1276:1997, 1997

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (Phase 1). London, UK:British Standards Institution;British Standard BS EN 1040:2005, 2005

Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. West Conshohocken, PA:ASTM International;ASTM Standard Test Method F 2101-07.

Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique. West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 1882-05.

Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemical Microbicides. West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2111-05.

Standard Test Method for Determining the Acivity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials . West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2180-01.

Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides. West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2197-02.

Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants. West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2274-03.

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents using the Fingerpads of Adult Subjects. West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2276-03E01.

Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection . West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2362-04.

Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency Washing Operations . West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2406-04.

Standard Test Method for Using Seeded-Agar for the Screening Assessment of Antimicrobial Activity In Carpets. West Conshohocken, PA:ASTM International;ASTM Standard Test Method E 2471-05.

Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area. Test method and requirements (Phase 2/Step 1) . London, UK:British Standards Institution;British Standard BS EN 13727:2003.

Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria. London, UK:British Standards Institution;British Standard BS ISO 21149:2006.

Cosmetics - Microbiology - Detection of Staphylococcus aureus. London, UK:British Standards Institution;British Standard BS ISO 22718:2006.

Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, sporicidal and fungicidal activity. London, UK:British Standards Institution;British Standard BS EN 12353:2006.

Chemical disinfectants and antiseptics --- Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas --- Test method and requirements without mechanical action (phase 2/step 2). London, UK:British Standards Institution;British Standard BS EN 13697:2001.

Chemical disinfectants and antiseptics --- Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area --- Test method and requirements (phase 2, step 2). London, UK:British Standards Institution;British Standard BS EN 14561:2006.

Chemical disinfectants and antiseptics --- Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on non-porous surfaces without mechanical action --- Test method and requirements (phase 2, step 2). London, UK:British Standards Institution;British Standard Draft BS EN 14349, 2006

Chemical disinfectants and antiseptics --- Application of European Standards for chemical disinfectants and antiseptics. London, UK:British Standards Institution;British Standard BS EN 14885:2006.

Textile fabrics --- Determination of antibacterial activity --- Agar diffusion plate test. London, UK:British Standards Institution;British Standard BS EN ISO 20645:2004.

Microbiology of food and animal feeding stuffs --- Guidelines on preparation and production of culture media --- Part 2: Practical guidelines on performance testing of culture media - Annex B: Recommended test microorganisms for commonly used culture media. London, UK:British Standards Institution;British Standard DD CEN ISO/TS 11133:2003.

U.S. Pharmacopeia General Chapters: <61> Microbial Examination of Nonsterile Products: Microbial Enumeration Tests. Rockville, MD USP34-NF29, 2011

Notice: Necessary PermitsPermits

These permits may be required for shipping this product:

  • Customers located in the state of Hawaii will need to contact the Hawaii Department of Agriculture to determine if an Import Permit is required. A copy of the permit or documentation that a permit is not required must be sent to ATCC in advance of shipment.
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