Enzymun-Test AFP

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

Full name

Enzymun-Test{r} Afp

Generic Name

KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

PMA Number

P860044 ↗

FDA Product Code

LOJ

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

APPR Approved

PMA Supplement

S002 (Normal 180 Day Track)

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• What clinical conditions is the Enzymun-Test AFP primarily used to evaluate or monitor?

  The Enzymun-Test AFP is designed to detect alpha-fetoprotein (AFP) levels in serum or plasma, which aids in diagnosing and monitoring testicular cancer as well as other conditions linked to elevated AFP, such as certain liver diseases or germ cell tumors. It supports clinical decision-making in immunology settings by providing quantitative measurements of AFP.

• Is the Enzymun-Test AFP intended for single-use or repeated testing in the same patient?

  The Enzymun-Test AFP is supplied as a single-use diagnostic kit, meaning each kit is intended for one test procedure. This design ensures accuracy and sterility per manufacturer guidelines, as repeated use could compromise reliability or introduce contamination risks.

• How is this test distributed, and what reference codes should buyers expect to encounter?

  The Enzymun-Test AFP is distributed under multiple FDA-assigned reference codes (e.g., 3002808328, 1036362, 3007111389) to facilitate inventory management. Buyers may encounter several codes depending on the specific lot or variant, so verifying the exact code with the manufacturer or distributor is recommended for ordering.

• What regulatory pathway was followed for FDA clearance of the Enzymun-Test AFP?

  The Enzymun-Test AFP received FDA clearance via a Premarket Approval (PMA) under PMA number P860044, which is the regulatory route for higher-risk Class II devices. This approval ensures the test meets stringent performance and safety standards for detecting AFP in serum/plasma, particularly for testicular cancer monitoring.

• Can this test be used outside a regulated clinical immunology lab, or is it strictly laboratory-only?

  The Enzymun-Test AFP is intended exclusively for use in regulated clinical immunology settings, as specified in its labeling. It requires laboratory processing and adherence to manufacturer instructions, so point-of-care or non-laboratory use is not authorized. This aligns with its classification under FDA regulation 866.6010 for in vitro diagnostic use.