← Product Code [GMD](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMD) · K930418

# CRYPTO-LEX SYSTEM (K930418)

_Trinity Laboratories, Inc. · GMD · Feb 17, 1994 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMD/K930418

## Device Facts

- **Applicant:** Trinity Laboratories, Inc.
- **Product Code:** [GMD](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMD.md)
- **Decision Date:** Feb 17, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3165
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to identify antibodies to Cryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identify Cryptococcus neoformans directly from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain membranes) and, if not treated, are usually fatal.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMD/K930418](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMD/K930418)

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