Cryopreserved ampule of Diseased Human Lung Fibroblasts, Idiopathic Pulmonary Fibrosis (DHLF-IPF) containing ≥ 500,000 cells

E-Delivered copy of the documents used to design, assess risk, test and validate WinKQCL^® 6 Software

X-VIVO^® 15, with L-Glutamine, gentamicin, recombinant transferrin, and phenol red, xenofree, 1 L

X-VIVO^® 15, Serum-free hematopoietic cell medium, with L-Glutamine, gentamicin and phenol red, xenofree, 500mL

Culture system containing MEBM^® Basal Medium (CC-3151) and MEGM^® SingleQuots^® Supplements (CC-4136) required for growth of Mammary Epithelial Cells.

EGM^®-Plus Endothelial SingleQuot^® Kit

Routine endotoxin determination of each additional sample sent in the same shipment under part code 80-503.

WinKQCL^® 5 Software Qualification Manual for installation, operation, and performance qualification 

STAT: Final product release test for up to 3 samples of a single batch performed in 4 business days or less.

WinKQCL^® 6 Endotoxin Detection and Analysis Software Package is a fully-integrated, 21CFR part 11 compliant solution for quantitative endotoxin detection analysis, data management, reporting, and trending. (Disc copy)