Tandem(R)-E Afp
PMA P840035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840035 | Date6 Mar 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- PMA Number
- FDA Product Code
- LOJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The Tandem-E AFP is a kit, test, alpha-fetoprotein for testicular cancer, classified as a 2-site immunoenzymatic sandwich assay. It is designed to quantitatively measure alpha-fetoprotein (AFP) levels in serum or plasma, a biomarker associated with testicular cancer and other hepatic conditions. This assay employs monoclonal antibodies to detect AFP through a chemiluminescent reaction, enabling precise diagnostic evaluation.
This device is supplied as a single-use reagent kit and requires use with compatible instrumentation, such as the Beckman Coulter UniCel DXI 800 system. It is intended for in vitro diagnostic use in clinical laboratories, adhering to regulatory standards under FDA PMA approval (P840035). Sterility and proper storage conditions are critical, as outlined in manufacturer guidelines, to maintain assay integrity. The product is categorized under OpenFDA device class 2 and medical specialty Immunology, with multiple registration numbers for tracking.
Other devices from Beckman Coulter, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Tandem-E AFP test used for in clinical practice?
The Tandem-E AFP is a quantitative immunoenzymatic sandwich assay designed to measure alpha-fetoprotein (AFP) levels in serum or plasma. AFP is a biomarker linked to testicular cancer as well as certain hepatic conditions, so this test aids in diagnostic evaluation for those conditions by providing precise measurement of AFP concentrations.
How is the Tandem-E AFP supplied, and is it reusable?
The Tandem-E AFP is supplied as a single-use reagent kit, meaning each kit is intended for one-time use only. It requires compatible instrumentation, such as the Beckman Coulter UniCel DXI 800 system, for operation. Reuse is not recommended as it could compromise assay integrity and accuracy.
What storage and sterility requirements apply to the Tandem-E AFP?
The Tandem-E AFP is sterile and must be stored under conditions specified by the manufacturer to preserve its performance. Improper storage—such as exposure to extreme temperatures or contamination—could degrade the reagent’s effectiveness. Always follow the manufacturer’s guidelines for handling and storage to maintain assay validity.
Does the Tandem-E AFP come in multiple sizes or models?
The Tandem-E AFP is a single test format (a kit for AFP measurement) and does not appear to offer variable sizes or models based on the provided data. It is a standardized immunoassay designed for use with compatible instrumentation, with no additional variants listed.
What regulatory pathway does the Tandem-E AFP follow, and how is it classified?
The Tandem-E AFP follows the FDA Premarket Approval (PMA) pathway, with approval granted under PMA number P840035. It is classified as a Class 2 device under OpenFDA, categorized under the Immunology medical specialty. This classification reflects its role as an in vitro diagnostic test for biomarker measurement.