Acridine Orange
Acridine Orange is a nucleic acid-selective fluorescent dye used in histology and cytology to differentiate DNA and RNA in cells; it fluoresces green when bound to double-stranded DNA and red-orange when bound to single-stranded RNA, useful in cell cycle analysis and vital staining. 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 IDC, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IDC
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853187 | ACRIDINE ORANGE FLUORESCENT STAIN | Aug 13, 1985 | Substantially Equivalent | Advanced Medical Technology, Inc. |
| K812212 | ACRIDINE ORANGE STAIN | Sep 01, 1981 | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. |
| K810040 | ACRIDINE ORANGE STAIN | Feb 12, 1981 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K803304 | ACRIDINE ORANGE STAIN | Feb 12, 1981 | Substantially Equivalent | Remel Co. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.