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Immunoassay, Insulin-Like Growth Factor Binding Protein-1

FDA product code OAM · 1 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1550
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-01-25 – 2007-01-25

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.

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