Product:
Catalogue No.:
Lot No.:
Date of manufacture:
Date of expiry:
Nunc CryoBank Vial, 1.0 ml, Red
374120
60897839
November 2024
October 2029
Thermo Fisher Scientific confirms that the product supplied has been inspected andtested in accordance to relevant specifications
Test Description
Visual
Test of function
USP<85>Bacterial endotoxins test
USP<87>"Biological Reactivity test, In Vitro
USP <88>"Biological Reactivity test
Requirements
According to specification
According to specification
<0.25 endotoxins unit/ml
USP current edition
USP current edition
Result
Complies
Complies
Complies
Complies**
Complies**
In Vivo, USP Class Vl Test"
Leak Test
DNAse/RNAse test
lATA current edition
Negative
Complies**Complies
**Only performed once
***Performed at certain frequency
Sterility is obtained through irradiation according to IS0 11137 “sterilization of health careproducts -Radiation" with SAL 10-6
Quality assurance of the product is performed in accordance with the requirements of the QualityManagement System lS0 13485:2016,“Medical devicesQuality management systemsSystem requirements for regulatory purposes".
Suzhou Site