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U.S. Department of Health and Human Services

Product Classification

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Device mmp-9 test system
Regulation Description Osmolality test system.
Definition A visual, qualitative immunoassay for the in vitro detection of elevated levels of the mmp-9 protein in tear fluid from patients suspected of having dry eye.
Physical State Tear collection method and single use immunoassay test cartridge
Technical Method Immunoassay
Target Area Eyes
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePFQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1540
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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