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Immunoassay For Detection Of Amniotic Fluid Protein(S).

Immunoassay For Detection Of Amniotic Fluid Protein(S). is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NQM

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Class 1

21 CFR 862.1550

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Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

Definition

The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.

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