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AFP Mid-Pregnancy Reference Preparation

by Centers for Disease Control and Prevention PMA

Withdrawn United States

PMA P820077

Overview

This device is a calibrator for alpha-fetoprotein (AFP) in mid-pregnancy maternal serum, classified under the nomenclature for immunoassay reagents. It serves as a reference standard to ensure accurate measurement of AFP levels in diagnostic testing, aiding in the assessment of fetal health and potential complications such as neural tube defects.

Supplied as a sterile, single-use preparation, the AFP Mid-Pregnancy Reference Preparation is intended for laboratory use in immunoassay systems. It is regulated under an FDA Premarket Approval (PMA) with PMA number P820077 and falls under device class III. Storage and handling must comply with standard laboratory protocols for immunoassay calibrators to maintain stability and accuracy.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Withdrawn since 30 Nov 1984. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP820077 Date30 Nov 1984Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

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

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
CALIBRATOR FOR ALPHA-FETOPROTEIN IN MID-PREGNANCY MATERNAL SERUM
PMA Number
FDA Product Code
LTQ
Device Class
Class III
Advisory Committee
Immunology
FDA Decision
APWD Approval withdrawn

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Questions

  • What is the purpose of the AFP Mid-Pregnancy Reference Preparation?

    This device serves as a calibrator for alpha-fetoprotein (AFP) in mid-pregnancy maternal serum, ensuring accurate measurement of AFP levels in diagnostic testing to assess fetal health and potential complications like neural tube defects.

  • How is the AFP Mid-Pregnancy Reference Preparation supplied?

    It is supplied as a sterile, single-use preparation intended for laboratory use in immunoassay systems, requiring standard laboratory protocols for storage and handling to maintain stability and accuracy.

  • What is the regulatory status of this device?

    The device is regulated under an FDA Premarket Approval (PMA) with PMA number P820077 and falls under device class III, indicating it has undergone rigorous review for safety and effectiveness.

  • Can the AFP Mid-Pregnancy Reference Preparation be reused?

    No, it is supplied as a single-use preparation and should not be reused to ensure the accuracy and reliability of diagnostic testing results.