Methylene Blue, Tissue Stain
Methylene Blue Tissue Stain is a synthetic thiazine dye used as a histological and cytological stain to differentiate cell nuclei, bacteria, and other tissue structures under the microscope, aiding in pathological diagnosis and examination of biological specimens. 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 KFC, 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
- KFC
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K875310 | RETICULOCYTE STAIN | Feb 09, 1988 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K843919 | SPOTTEST LOEFFLER METHYLENE BLUE STAIN | Oct 30, 1984 | Substantially Equivalent | Difco Laboratories, Inc. |
| K842926 | METHYLENE BLUE STAIN, LOEFFLER | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | Sep 11, 1984 | Substantially Equivalent | Reagent Laboratory, Inc. |
| K842743 | NEW METHYLENE BLUE N | Aug 12, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K831502 | NEPHROLYTE | Jul 18, 1983 | Substantially Equivalent | Flaitron Laboratories, Inc. |
| K770792 | TUBE, STAIN, RETICULOCYTE, LARC | Jul 05, 1977 | Substantially Equivalent | Corning Medical & Scientific |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.