Laboratory Test Request

Cytological Cervical Spatula Medical Device FDA Submission Studies

Project Description

FDA cGMP Medical Device Laboratory needed for the following class II medical device for the following GLP Studies of a class II Cytological cervical spatula.medical device:

Sensitization: Magnusson-Kligman Method, 2 extracts
Polar and Non Polar extractions recommended. This service may be subcontracted to another
facility.

1.) Irritation: Vaginal, Device method, 2 extracts
Cytotoxicity: MEM elution, 48 hr inc., L929, 24 hr ext (non-implant)
2.) Metals Only Analysis via ICP/MS (46 Element Quant.)
3.) pH Analysis
4.) USP Physicochemical: Aqueous extraction fee
5.) GLP fee
6.) GLP fee (subcontract)

Project Information

Number:23-02376

Industry:Medical Devices

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