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AutoDELFIA hAFP Test Kit

FDA PMA

Class III (US FDA PMA)

PMA P970037

by Revvity, Inc.

Identity

Trade Name
AUTODELFIA HAFP TEST KIT FDA PMA
Generic Name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS FDA PMA

Identifiers

PMA Number
P970037 FDA PMA
FDA Product Code
LOK FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Immunology FDA PMA
FDA Decision
APPR Approved FDA PMA

The AutoDELFIA hAFP Test Kit is an immunoassay device designed for the quantitative determination of human alpha-fetoprotein (AFP) in maternal serum and amniotic fluid. It falls under the category of a test kit for detecting neural tube defects and is intended for use between the 15th and 21st weeks of gestation. The assay is performed on the 1235 AutoDELFIA automatic immunoassay system and is classified as a Class III device under FDA regulations.

This test kit is supplied as a single-use diagnostic tool and requires use in conjunction with other diagnostic tools such as ultrasound and amniography. It is authorized under FDA PMA (P970037) and is intended for laboratory use only. The kit is not MRI-safe, and storage conditions must adhere to manufacturer guidelines to maintain assay integrity. Multiple registration numbers (e.g., 3005360469) are associated with its regulatory filing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AutoDELFIA hAFP/Free hCGß Dual Kit | Revvity, AUTODELFIA HAFP TEST KIT (P970037) — FDA 510 (k) | Innolitics, AutoDELFIA immunoassay system for prenatal screening - Revvity, Revvity | Demo, AutoDELFIA hAFP Test System PMA P970037S010 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Revvity, Inc.

Sources (1)

  • FDA PMA P970037 24 fields · synced Sep 18, 2026