Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
A quantitative G6PD assay is a laboratory test that precisely measures the activity of glucose-6-phosphate dehydrogenase in erythrocytes, providing a numerical result used to confirm or rule out enzyme deficiency and assess its severity. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBL, regulated under 21 CFR 864.7360, within the Hematology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JBL
- Device Class
- FDA class 2
- Regulation Number
- 864.7360
- 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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.