Test, Screening, For D Positive Fetal Rbc'S
A screening test for D-positive fetal red blood cells is a hematology diagnostic device used to detect fetal red blood cells carrying the D (Rh) antigen in the maternal circulation, used to quantify fetal-maternal hemorrhage and guide the dosing of Rh immunoglobulin in Rh-negative pregnant women or postpartum patients. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIM and is regulated under 21 CFR 864.7455 within the Hematology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LIM
- Device Class
- FDA class 2
- Regulation Number
- 864.7455
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.