Laboratory Testing Services

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ISO 10993-1, ISO 10993-3, OECD TG471
Biocomp - Genotox - AMES test

Bacterial reverse mutation assay with/without metabolic activation
ISO 10993-1, ISO 10993-23
Biocomp - in vivo Ocular Irritation

Rabbit eye irritation test (Draize method)
USP 88
Biocomp - USP Class VI - Acute systemic toxicity

Mouse systemic toxicity per USP Class VI requirements
ISO 10993-1, ISO 10993-12, ISO 10993-23
Biocomp - in vivo intracutaneous reactivity

Rabbit intradermal injection of polar/non-polar extracts
ISO 11737-1, ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-18, USP 71, USP 467
Complex Test Product UPDATED

GC-MS extraction method
ISO 10993-1, ISO 10993-23
Biocomp - In Vitro Irritation Test (Medical device 10993-23)

MatTek EpiDerm™ reconstructed human epidermis model
USP 88
Biocomp - USP Class VI - Intramuscular implantation test

Rabbit muscle implantation, histopathology evaluation
ISO 10993-1, ISO 10993-12, ISO 10993-23
Biocomp - in vivo skin Irritation

Rabbit skin application, 4h exposure, 72h observation
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - direct contact

L929 cells, 24h direct contact, morphology assessment
ISO 10993-12, ISO 10993-18, USP 467
IPA residual solvant testing

Extraction in DMF, GC-FID quantification
USP 88
Biocomp - USP Class VI - Intracutaneous test

Rabbit intracutaneous reactivity test with extracts
ISO 10993-1, ISO 10993-11, USP 151
Biocomp - Material mediated pyrogenicity

Rabbit pyrogen test, saline extract, temperature monitoring
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - indirect contact

Agar overlay method with L929 cells, zone assessment
ISO 10993-1, ISO 10993-4
Biocomp - Hemocompatibility - Hemolysis (material induced)

Direct/extract contact with RBCs, hemoglobin release
ISO 10993-1, ISO 10993-11, USP 151
Biocomp-Material med pyrogenicity GLP

GLP-compliant rabbit pyrogen test with saline extract
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - extract (XTT)

L929 cells exposed to extracts, XTT viability assay
ISO 10993-1, ISO 10993-3, OECD TG471
Biocomp - Genotox - Mouse Lymphoma Assay (MLA, Limit test)

Mammalian cell forward mutation assay with colony sizing
ISO 10993-1, ISO 10993-23
Biocomp- Acute oral irritation

Hamster cheek pouch or oral mucosa irritation test
ISO 10993-1, ISO 10993-10, ISO 10993-12
Biocomp - in vivo acute systemic toxicity

Mouse systemic injection, polar/non-polar extracts
ISO 10993-1, ISO 10993-10, ISO 10993-12
Biocomp - in vivo sensitization - GPMT

Guinea pig maximization test, polar/non-polar extracts

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