IDC · Acridine Orange
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | IDC |
|---|---|
| Device Name | Acridine Orange |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K853187 | ACRIDINE ORANGE FLUORESCENT STAIN | Advanced Medical Technology, Inc. | Aug 13, 1985 | SESE |
| K812212 | ACRIDINE ORANGE STAIN | Carr-Scarborough Microbiologicals, Inc. | Sep 1, 1981 | SESE |
| K810040 | ACRIDINE ORANGE STAIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 12, 1981 | SESE |
| K803304 | ACRIDINE ORANGE STAIN | Remel Co. | Feb 12, 1981 | SESE |
Top Applicants
- Advanced Medical Technology, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Carr-Scarborough Microbiologicals, Inc. — 1 clearance
- Remel Co. — 1 clearance
