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Captia Syphilis-M

by Mercia Diagnostics, Ltd.

510(k) K871548

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871548 Date7 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Captia(R) Syphilis-M
510(k) Number
FDA Product Code
LIP
FDA applicant
Mercia Diagnostics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 866.3830
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Captia Syphilis-M is an enzyme linked immunoabsorption assay for Treponema pallidum. It functions as a diagnostic tool within the field of microbiology to detect specific antibodies.

This device is a Class II medical device that has received FDA 510(k) clearance. It is manufactured by Mercia Diagnostics, Ltd. and is identified by product code LIP.

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