Crystal Violet For Histology
Crystal Violet for Histology is a triphenylmethane dye used in histological staining procedures to stain nuclei and certain tissue components violet-purple, and is also a component of the Gram staining technique for differentiating bacteria. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is ICF, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
Basic Information
- Product Code
- ICF
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K864531 | TISSUE GRAM STAIN | Dec 22, 1986 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | Oct 01, 1984 | Substantially Equivalent | American Dade |
| K842730 | GENTIAN VIOLET | Aug 03, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K821503 | IRIS URINE STAIN | Jun 03, 1982 | Substantially Equivalent | Intl. Remote Imaging Systems |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Dec 18, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.