NAL

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Test, Immunoassay, Biosensor, Hcg

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1155

Medical specialty

Clinical Chemistry

Flags

Third-party review eligible

Adverse events (MAUDE)

2016: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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