Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3830](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3830) → GMR — Sera, Reactive And Non-Specific Control, Fta-Abs Test

# GMR · Sera, Reactive And Non-Specific Control, Fta-Abs Test

_Microbiology · 21 CFR 866.3830 · Class 2_

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

## Overview

- **Product Code:** GMR
- **Device Name:** Sera, Reactive And Non-Specific Control, Fta-Abs Test
- **Regulation:** [21 CFR 866.3830](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3830)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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