Certificate of Analysis
Becton Dickinson and Company
BD Diagnostic Systems
PO Box 999
Sparks MD 21152-0999 US Page: 1 of 2
Product Name : Bottle Selenite Cystine Broth 500G
Catalog Number : 268740 Manufacture Date: 2020/02/04
Batch Number : 0076951
Expiration Date : 2022/01/31
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01. Dehydrated Medium Appearance: Off-white, free-flowing, homogeneous
02. Solubility: 2.3% solution, soluble in distilled or deionized
water on boiling
03. Solution Appearance: Very light amber, may have a trace tint of
pink orange, clear to very slightly opalescent, may have a
slight precipitate.
04. Cultural Response: Medium was prepared per label instructions.
Tubes were inoculated with the test organisms, incubated at
35 ± 2°C for 24 ± 2 hours and then subcultured on MacConkey Agar.
COLONY APPEARANCE
IT ORGANISMS ATCC® RECOVERY ON MACCONKEY AGAR
Escherichia coli 25922 partial to pink w/bile ppt.
complete inhibition
Salmonella typhimurium 14028 good colorless
Shigella sonnei 9290 air to good colorless
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Lower Upper
Characteristic Unit Value Limit Limit
_______________________________________________________________________
pH at 25°C : 7.1 6.8 7.2
Bulk Lot Number : - 0027055
_______________________________________________________________________
_______________________________________________________________________
Animal source Country of Tissue Category
Origin BIC SIC ABC
_______________________________________________________________________
Avian China IV IV NDF
Bovine New Zealand IV IV MLK
Bovine USA IV IV MLK
Porcine USA III III IB
_______________________________________________________________________
For an avian origin ingredient used in the manufacture of this product,
the BD supplier is not able to confirm animal health. The supplier has
confirmed that the ingredient undergoes extensive processing that
includes exposure to strong acid, filtration, crystallization, and
drying.
The Batch Number on this certificate is synonymous with the Lot Number
shown on the product label.
BD Diagnostics - Diagnostic Systems products are manufactured in ISO
13485:2016 Registered facilities. In addition, BD Diagnostics -
Diagnostic Systems facilities are registered with the United States
Creation Date: 2020/05/18 16:11:54
Certificate of Analysis
Becton Dickinson and Company
BD Diagnostic Systems
PO Box 999
Sparks MD 21152-0999 US Page: 2 of 2
Product Name : Bottle Selenite Cystine Broth 500G
Catalog Number : 268740 Manufacture Date: 2020/02/04
Batch Number : 0076951
Expiration Date : 2022/01/31
_______________________________________________________________________
Food and Drug Administration (FDA), and are regulated by the FDA's
Quality System Regulations (QSRs). This product met BDDS stringent
quality standards at time of batch/lot release. Any test results
reported on this certificate were obtained at time of release. This
material is not for human or animal consumption.
BD Diagnostics - Diagnostic Systems' Certificates of Analysis (COA)
typically contain animal origin information when products are
manufactured using materials of animal origin. This information may
be contained in the animal source table and/or in one or more of the
additional paragraphs found on the COA. Following Quality Control
release, the COA is created and published at www.bd.com/regdocs. For
each batch of finished product that contains animal origin raw
materials, the COA shows the animal origin data from the individual
lots of animal origin raw materials used, as provided by the raw
material suppliers.
At times, suppliers notify BD Diagnostics - Diagnostic Systems of new
and/or additional information they have received from their raw
material suppliers that modifies the animal origin information for lots
previously provided to BD. See "COA Animal Origin Information Position
Statement" located at www.bd.com/regdocs under "Position Statements"
for the impact that retrospective information has on COAs and on
customers enrolled in the BDDS and BDAB Automated Change Notification
Program.
For complete details on animal origin information, refer to "BD
Diagnostics - Diagnostic Systems, Animal Origin Position Statement", at
www.bd.com/regdocs under "Position Statements".
Manufacturer is Becton Dickinson and Company, 7 Loveton Circle, Sparks,
MD 21152 USA. To determine location of manufacturing for this product,
please see
www.bd.com/en-us/support/bd-life-sciences-diagnostic-systems-customer-
regulatory-support-information.
Megan Reeher
Associate Director, Quality Management
Creation Date: 2020/05/18 16:11:54
