ICN · Biebrich Scarlet
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | ICN |
|---|---|
| Device Name | Biebrich Scarlet |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833273 | MASSON TRICHROME STAIN HT15 | Sigma Chemical Co. | Oct 31, 1983 | SESE |
| K822128 | VOLU-SOL SINGLE DIFFERENTIAL STAIN | Volu Sol Medical Industries | Aug 5, 1982 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
