Ultimate Grade FBS Certificate of Analysis

CERTIFICATE OF ANALYSIS
Product:
Grade:
Part Number:
Lot Number:
Total Volume:
Fetal Bovine Serum
Ultimate
1600
Example
520.0 Liters
Product Origin:
Filtration:
Manufacture Date:
Expiration Date:
Storage:
Collected and Processed in USA
Triple 0.1µm Sterile Filtered
August 2014
September 2019
-10°C to -20°C
CERTIFIED ANALYSIS
Test/Method
Bovine Viral Diarrhea Virus (qPCR Technology)
Endotoxin (Limulus Amebocyte Lysate-Gel Clot, USP 85)
Hemoglobin (Fleming & Woolf)
Sterility (Current USP and EP 2.6.1 for Bacteria & Fungi)
Mycoplasma (Barile & Kern)
pH (USP 791)
Osmolality (USP 785)
Virus Testing (9 CFR 113.53c)
Bluetongue
Bovine Adenovirus
Bovine Parvovirus
Bovine Respiratory Syncytial Virus
Bovine Viral Diarrhea Virus
Rabies
Reovirus
Cytopathogenic Agents (IBR)
Hemadsorbing Agents (PI3)
Unit of Measure
N/A
EU/mL
mg/dL
N/A
N/A
N/A
mOsm/KgH20
Specification
Not Detected
<10
<25
No Growth
Not Detected
Test & Report
Test & Report
Result
Not Detected
<1.0
10.0
No Growth
Not Detected
7.1
292.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
Not Detected
BIOCHEMICAL ASSAY
Test/Method
Albumin
Alkaline Phosphatase
ALT (SGPT)
AST (SGOT)
Bilirubin – Total
Calcium
Chloride
Cholesterol
Creatinine
Glucose
IgG (ELISA)
Phosphorus
Potassium
Protein – Total
Unit of Measure
gm/dL
U/L
U/L
U/L
mg/dL
mg/dL
mEq/L
mg/dL
mg/dL
U/L
ug/dL
mg/dL
mEq/L
gm/dL
Result
2.2
224.0
6.0
44.0
0.3
15.0
99.0
32.0
2.4
91.0
85.0
9.4
>10.0
3.5
Test/Method
Sodium
Triglycerides
Urea Nitrogen (BUN)
Uric Acid
Electrophoretic Profile
Hormone Profile
Cortisol
Estradiol
Insulin
Progesterone
T3 Baseline
T4 Baseline
Testosterone
Unit of Measure
mEq/L
mg/dL
mg/dL
mg/dL
N/A
Result
135.0
59.0
18.0
2.4
Definitive
ug/dL
pg/mL
uIU/mL
ng/mL
ug/dL
ng/mL
ng/mL
<0.2
24.07
5.72
<0.05
0.65
10.92
0.19
Contact Information · Phone 435-554-8069 · Fax 435-565-4432 · Email [email protected] · Web www.seradigm.com
Lot Example Page 1 of 2
STATEMENTS
Statement of Origin: This product was manufactured from fetal bovine blood collected exclusively from approved
harvest facilities. All fetal bovine serum used in this product is derived from fetuses collected from cows that are of
United States origin and have passed ante- and post-mortem inspection. All harvest facilities are USDA inspected and
located within the continental United States of America. All collection and processing activities are performed under the
strict guidance of standard operating procedures.
Statement of Intended Use: This product is intended for further manufacturing or research use. This product is not
intended for human or therapeutic use.
Statement of Manufacturing: This product was manufactured under current Good Manufacturing Practices (cGMP).
ISIA Certified Traceability: All raw serum is certified by the International Serum Industry
Association (ISIA) to be sourced in accordance with their strict traceability guidelines
(www.serumindustry.org).
ISIA Compliant Documentation: This document complies with all documentation
standards issue by the ISIA regarding the definition, quality control, country of origin
and certified analysis of fetal bovine serum (www.serumindustry.org).
QC DEPARTMENT APPROVAL
Electronic Signature:
Date: 15 September 2014
Sherrie Drake Hirschi
Contact Information · Phone 435-554-8069 · Fax 435-565-4432 · Email [email protected] · Web www.seradigm.com
Lot Example Page 2 of 2

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