Immunoassay For Detection Of Amniotic Fluid Protein(S).

NQM · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1550

Classification

FDA Product Code: NQM
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.1550
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown