Identity
- Trade Name
- AMERSHAM AFP FDA PMA
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS FDA PMA
Identifiers
- PMA Number
- P780006 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
- PMA Supplement
- S002 FDA PMA
The Amersham Afp is an alpha-fetoprotein test kit designed for the detection of neural tube defects. This diagnostic device is classified as a kit for testing alpha-fetoprotein levels in clinical settings.
This device is manufactured by Ortho-Clinical Diagnostics, based in Rochester, New York. It is regulated under FDA PMA number P780006.
Frequently asked questions
What is the primary purpose of the Amersham Afp kit?
The Amersham Afp is a test kit specifically designed for the detection of alpha-fetoprotein, which is used in the clinical assessment of neural tube defects.
Who is the manufacturer of this test kit?
The Amersham Afp test kit is manufactured by Ortho-Clinical Diagnostics, located in Rochester, New York.
Is this device regulated by the FDA?
Yes, the Amersham Afp is regulated by the FDA under the Premarket Approval (PMA) process, specifically identified by PMA number P780006.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P780006 | Class III | Active |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
- FDA Applicant
- Ortho Clinical Diagnostics
Sources (1)
- FDA PMA P780006 24 fields · synced Sep 18, 2026