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Access AFP Reagents

by Beckman Coulter, Inc.

PMA P980041

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 P980041↗

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 NumberP980041 Date8 Feb 1999ApprovedStatusActive

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  • Withdrawn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
Access Afp Reagents on the Access Immunoassay Systems
Trade Name
Access Afp Immunoassay System
Generic Name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
PMA Number
FDA Product Code
LOK
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.

The Access AFP Reagents are a paramagnetic particle, chemiluminescent immunoassay designed for use with the Access Immunoassay System. This diagnostic tool provides the quantitative determination of alpha-fetoprotein (AFP) in human serum to assist in the management of patients with non-seminomatous testicular cancer.

Additionally, the assay is used for the analysis of maternal serum and amniotic fluid between 15 and 20 weeks of gestation to aid in the detection of fetal open neural tube defects. It is intended to be used in conjunction with other diagnostic procedures, such as ultrasound and amniography, and has received FDA PMA authorization.

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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 primary clinical use of the Access AFP Reagents?

    The reagents are used for the quantitative determination of alpha-fetoprotein (AFP) to help manage patients diagnosed with non-seminomatous testicular cancer.

  • Can this assay be used to detect fetal neural tube defects?

    Yes, the assay is indicated for use with maternal serum and amniotic fluid at 15 to 20 weeks gestation to aid in the detection of fetal open neural tube defects.

  • Should this test be used as a standalone diagnostic tool?

    No, the Access AFP assay is intended to be used in conjunction with other diagnostic tools, such as ultrasound and amniography, to provide a comprehensive clinical assessment.