Zendura® A Biocompatibility Report List updated 22 Apr 2019

ISO req
# Test Report ID Report Date Lab Filename
satisfied
1 Class VI Systemic 11C0354 Apr 20, 2011 Pacific Systemic Inj. Pacific
Injection Test, USP H-X02G BioLabs BioLabs Study No.
<88>rev. 10/2010 11C0354H-X02G_edited
2 Class VI Intracutaneous 11C0354 Apr 19, 2011 Pacific Intracutaneous. Pacific
Test, USP <88>rev. H-X03G BioLabs BioLabs Report No.
10/2010 11C0354H-X03G_edited
3 Class VI – Intramuscular 11C0354 Apr 14, 2011 Pacific Intramuscular. Pacific
Implant Test, USP<88>, H-X04G BioLabs BioLabs Study No.
rev. 10/2010 11C0354H-X04G_edited
4 Cytotoxicity Elution Test 11G0396 Aug 19, 2011 Pacific Cytotox. Pacific BioLabs
(MEM Extract) ISO 10993-5 H-M01G BioLabs Study No. 11G0396H-
ISO 10993-5:2009 M01G
5 Intracutaneous 11G0396 Aug 18, 2011 Pacific Intracutaneous. Pacific
ISO 10993-
(Intradermal) Reactivity H-X03G BioLabs BioLabs Study No.
10
Test, ISO 10993-10:2010 11G0396H-X03G

6 Oral Mucosa Irritation 11G0396 Sep 12, 2011 Pacific Irritation. Pacific
ISO 10993-
Test, ISO 10993-10:2010 H-X04G BioLabs BioLabs Study No.
10
11G0396H-X04G
7 Maximization Test for 11G0396 Sep 9, 2011 Pacific Hypersens. Pacific
Delayed-Type ISO 10993- H-X02G BioLabs BioLabs Study
Hypersensitivity ISO 10 No.11G0396H-X02G
10993-10:2010
8 ISO Subacute 74815 May 23, 2017 WuXi ISO Subacute Toxicity
ISO 10993-
Intraperitoneal Toxicity AppTec Study
11
ISO 10993-11
9 ISO Bacterial 67083 Apr 10, 2017 WuXi Ames Assay
Mutagenicity Test – AppTec D00022579001-
ISO 10993-3
Ames Assay 190862.1-1
ISO 10993-3
10 ISO Cytotoxicity, W-W- Nov 17, 2016 China W-W-0749-2016
In Chinese
Sensitization, Irritation, 0749-
only
Genotoxicity 2016
11 ISO Subchronic toxicity W-W- Mar 1, 2017 China W-W-0750-2016
In Chinese
0750-
only
2016