LAL test (Limulus Amebocyte Lysate)
1. Biological Effect: Material mediated pyrogenicity
2. Turnaround time: 4 weeks
3. Sample Requirements:
ISO
12 cm² (test item < 0.5 mm thick);
6 cm² (test item ≥ 0.5 mm thick);
1 gram;
2 ml;
at least 1 item;
ISO 10993-11
Medical device is extracted in Water for injection according to ISO 10993-12. The extract’s content of bacterial endotoxin is measured by the chromogenic reaction of the LAL reagent and chromogenic substrate. Quantitative result is accompanied with product-specific validation.
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Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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