NQM — Immunoassay For Detection Of Amniotic Fluid Protein(S). Class I
Classification Details
- Product Code
- NQM
- Device Class
- Class I
- Regulation Number
- 862.1550
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.