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U.S. Department of Health and Human Services

Product Classification
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Device dna probe, nucleic acid amplification, chlamydia
Regulation Description Chlamydia serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMKZ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3120
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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