Qualitycert 000000000000211898 7305526

Certificate of Analysis
Becton Dickinson and Company

BD Diagnostic Systems
PO Box 999
Sparks MD 21152-0999 US Page: 1 of 2
Product Name : Tube Penicillinase 10000000 KU/ml 10 Ea

Catalog Number : 211898 Manufacture Date: 2017/11/15
Batch Number : 7305526
Expiration Date : 2018/10/26
_______________________________________________________________________
Representative samples of this lot were tested by the BD
Quality Control Laboratory and were found to be in
compliance with BD performance and Sterility Test.
Assay results were as stated below. Sterility Testing
was performed by incubating at 20-25°C and 30-35°C for
14 days.
_______________________________________________________________________
Lower Upper
Characteristic Unit Value Limit Limit
_______________________________________________________________________
Assay Results : KU/ml 11600000 10000000 18000000
_______________________________________________________________________
_______________________________________________________________________
Animal source Country of Tissue Category
Origin BIC SIC ABC
_______________________________________________________________________
Bovine New Zealand IV IV MLK
Porcine Canada IV IV IB
Porcine USA III III IB
Porcine USA IV IV IB
_______________________________________________________________________
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
9001:2008 Registered facilities. In addition, BD Diagnostics -
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.
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 http://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
Creation Date: 2017/12/06 17:58:05

Certificate of Analysis
Becton Dickinson and Company
BD Diagnostic Systems
PO Box 999
Sparks MD 21152-0999 US Page: 2 of 2
Product Name : Tube Penicillinase 10000000 KU/ml 10 Ea

Catalog Number : 211898 Manufacture Date: 2017/11/15
Batch Number : 7305526
Expiration Date : 2018/10/26
_______________________________________________________________________
material suppliers that modifies the animal origin information for lots
previously provided to BD. See "COA Animal Origin Information Position
Statement" located at http://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
Position Statement - BD Diagnostic-Diagnostic Systems, COA Animal
Origin Information Position Statement", at http://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/ds/technicalCenter/regulatory.asp.
Stability data for this product is on file.
Charlotte Dannenfelser
BD Life Sciences - Diagnostic Systems
Quality Director, Microbiology
Signature Date:2017/12/06
Creation Date: 2017/12/06 17:58:05

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Certificate of Analysis

Becton Dickinson and Company

Product Name : Tube Penicillinase 10000000 KU/ml 10 Ea

Creation Date: 2017/12/06 17:58:05

Product Name : Tube Penicillinase 10000000 KU/ml 10 Ea

Creation Date: 2017/12/06 17:58:05

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