Brilliant Cresyl Blue
Brilliant Cresyl Blue is a supravital dye used in hematology to stain reticulocytes in blood smears, enabling visualization and counting of reticulocytes under the microscope as an indicator of red blood cell production and bone marrow activity, supporting diagnosis of anemia and hematopoietic disorders. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KJN, regulated under 21 CFR 864.1850, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KJN
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K821318 | RETIC SET | Jun 02, 1982 | Substantially Equivalent | R&D Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.