With the rapidly prevalent spread of Covid 19, medical devices industries around the globe have been increasing production at a similar speed in order to deliver us the protection we need. At Makmal Bioserasi we offer testing in accordance to the ISO 10993 series.
- MEM Elution.
- MTT Assay.
- Animal Irritation Test.
- Intracutaneous Reactivity Test.
Skin Sensitization Tests
- Buehler Sensitization Method.
- Guinea Pig Maximisation Test (Magnusson-Kligman).
Systemic Toxicity Tests
- Acute Intraperitoneal.
- Acute Intravenous.
- Rabbit Pyrogen Test.
- Bacterial Reverse Mutation (AMES) Test.
- In vitro Micronucleus Test.
- ISO 10993
- OECD Test Guideline Pharmacopoeia (USP)
- Medical Device Regulations 2012, Malaysia
- US FDA Regulatory Guideline