Immunoassay, Insulin-Like Growth Factor Binding Protein-1

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

Classification

FDA Product Code: OAM
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 device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 12

Source

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