Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart B — Biological Stains](/submissions/HE/subpart-b%E2%80%94biological-stains) → [21 CFR 864.1850](/submissions/HE/subpart-b%E2%80%94biological-stains/864.1850) → LEF — Stains, Dye Powder

# LEF · Stains, Dye Powder

_Hematology · 21 CFR 864.1850 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/LEF

## Overview

- **Product Code:** LEF
- **Device Name:** Stains, Dye Powder
- **Regulation:** [21 CFR 864.1850](/submissions/HE/subpart-b%E2%80%94biological-stains/864.1850)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K871476](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/LEF/K871476.md) | SILVER STAIN REAGENT SYSTEM | Sigma Chemical Co. | May 21, 1987 | SESE |

## Top Applicants

- Sigma Chemical Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/LEF](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/LEF)

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