Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
A glucose-6-phosphate dehydrogenase (G6PD) erythrocytic screening test is a laboratory device used to detect deficiency of this enzyme in red blood cells, which can cause hemolytic anemia in affected individuals when exposed to certain drugs, infections, or foods. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JBF, 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
- JBF
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201049 | FINDER G6PD | Sep 14, 2022 | Substantially Equivalent | Baebies, Inc. |
| K161364 | BinaxNOW G6PD Test | Jun 17, 2016 | Substantially Equivalent | Alere Scarborough, Inc. |
| K080003 | BINAXNOW G6PD TEST | Oct 23, 2008 | Substantially Equivalent | Binax, Inc. |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Mar 31, 2003 | Substantially Equivalent | Pointe Scientific, Inc., |
| K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | Jun 29, 1995 | Substantially Equivalent | Sigma Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.