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U.S. Department of Health and Human Services

Product Classification

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Device amniotic fluid protein immunoassay
Regulation Description Urinary pH (nonquantitative) test system.
Definition To detect specified amniotic fluid proteins in cervicovaginal samples
Physical State dipstick or cassette
Technical Method Detects specified amniotic fluid proteins
Target Area Cervicovaginal fluid samples
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePDS
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1550
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons