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Truquant Br Ria

by Biomira, Inc.

PMA P950011

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P950011↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP950011 Date29 Mar 1996ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Truquant(R) Br(Tm) Ria
Generic Name
ANTIGEN, CANCER 549
PMA Number
FDA Product Code
MJB
Device Class
Class III
Advisory Committee
Immunology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

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

Truquant Br Ria is an in vitro diagnostic device defined as an Antigen, Cancer 549 test. It is designed for the detection of Cancer Antigen 549 in clinical specimens using radioimmunoassay (RIA) methodology.

The device is supplied as a test kit for laboratory use. It received FDA Premarket Approval (PMA) under number P950011 on March 29, 1996, and is classified as a Class III device. No information is provided regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions.

Other devices from Biomira, Inc.

Questions

AI-generated answers, 18 Sep 2026

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

  • What is the Truquant Br Ria used for?

    The Truquant Br Ria is an in vitro diagnostic device intended for the detection of Cancer Antigen 549. It uses radioimmunoassay (RIA) methodology to measure this antigen in clinical specimens, as defined by its generic name and device classification.

  • Who manufactures the Truquant Br Ria and when was it approved?

    The Truquant Br Ria is manufactured by Biomira, Inc. It received FDA Premarket Approval (PMA) on March 29, 1996, with PMA number P950011, following an expedited review process.

  • What regulatory classification does the Truquant Br Ria have?

    The Truquant Br Ria is classified as a Class III medical device by the FDA, with the generic name 'Antigen, Cancer 549' and product code MJB. This classification is based on its PMA approval and openFDA device listing.