Stain, Fetal Hemoglobin
Stain, Fetal Hemoglobin (product code GHQ) is a hematology staining reagent used to identify red blood cells containing fetal hemoglobin (HbF) in blood smears, applied in the Kleihauer-Betke test and related methods for detecting fetomaternal hemorrhage and hemoglobinopathies. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.7455 in the Hematology specialty (HE), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GHQ
- Device Class
- FDA class 2
- Regulation Number
- 864.7455
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
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 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.