Assay, Fetal Hemoglobin
This device is a fetal hemoglobin assay, an in vitro diagnostic test used to detect and quantify fetal hemoglobin (HbF) in blood samples, used in the evaluation of hemoglobinopathies such as sickle cell disease and thalassemia, and in the identification of fetomaternal hemorrhage. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQI, regulated under 21 CFR 864.7455 within the Hematology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KQI
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880653 | HBF DILUENT | Apr 21, 1988 | Substantially Equivalent | Helena Laboratories |
| K812226 | HELENA HBF QUIPLATE CONTROL | Sep 01, 1981 | Substantially Equivalent | Helena Laboratories |
| K810475 | HELENA HEMOGLOBIN F CONTROLS | Mar 26, 1981 | Substantially Equivalent | Helena Laboratories |
| K791143 | SICKLE-CELL F TEST | Jul 17, 1979 | Substantially Equivalent | Isolab, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.