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Biocompatibility Studies for Medical Devices.

Biocompatibility Studies are conducted as per ISO/IEC 17025: 2005 for the testing of medical devices. In accordance with ISO, US FDA, and regulatory approval criteria for CE marking, our team of highly qualified scientists thoroughly assesses your equipment for biological compatibility.

Cytotoxicity Test

  • Agarose Overlay
  • MEM Elution
  • Direct Contact
  • Quantitative Test by MTT Test, XTT Test, Neutral Red Uptake (NRU), Colony Formation

Irritation and Skin sensitization

  • Intracutaneous Reactivity
  • Mucosal Irritation (vaginal, rectal, oral)
  • Ocular Irritation & Intraocular Irritation
  • Primary Skin Irritation Test
  • Closed Patch (Buehler) Dermal sensitization
  • Guinea Pig Maximisation Test (Magnusson-Kligman)
  • Local Lymph Node Assay (LLNA) by BrdU ELISA

Systemic Toxicity

  • Acute Systemic Toxicity
  • Sub-Acute Toxicity
  • Chronic systemic toxicity
  • Sub-chronic Toxicity
  • Reproductive Toxicity

Genotoxicity Studies

  • Chromosome Aberration Test
  • Bone Marrow Chromosome Aberration Test
  • Micronucleus Assay
  • Bacterial Reverse Mutation Test (Ames test)
  • Comet Assay

Others

  • Reproductive and Developmental Toxicology Studies
  • Carcinogenicity Test
  • Teratogenicity

Hemocompatibility

  • ASTM Hemolysis
  • Prothrombin time (PT)
  • Complement assay (C3a and SC5b-9)
  • Platelet Aggregation / Activation
  • Leukocyte Activation Test
  • Haematology Test

Local effects after implantation

  • Intramuscular Implantation
  • Subcutaneous Implantation
  • Bone Implantation
  • Ocular Implantation

Pyrogenicity

  • Material Mediated Rabbit Pyrogenicity Test
  • In vitro Bacterial Endotoxins

Plastics (USP Class (I-VI))

  • Biological Reactivity Tests

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