ZEUS ELISA Parvovirus B19 IgG Test System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM FDA PMA
- Generic Name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG FDA PMA
Identifiers
- PMA Number
- P150045 FDA PMA
- FDA Product Code
- MYL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ZEUS ELISA Parvovirus B19 IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to human parvovirus B19 in human serum. It is classified as a Class III in vitro diagnostic device and is intended for use in microbiology to aid in diagnosing parvovirus B19 exposure, particularly in women of childbearing age and symptomatic patients suspected of fifth disease (erythema infectiosum).
This test system is supplied as an in vitro diagnostic device and requires use in a clinical laboratory setting. It is intended for single-use and must be handled according to standard laboratory protocols for infectious disease testing. The system carries an FDA Premarket Approval (PMA) under PMA number P150045, ensuring compliance with regulatory requirements for diagnostic accuracy and safety. Storage and handling instructions are specified in the accompanying documentation.
Frequently asked questions
What clinical scenarios is the ZEUS ELISA Parvovirus B19 IgG Test System primarily used for diagnosing?
This test is designed to help diagnose parvovirus B19 exposure, particularly in women of childbearing age who may have been exposed, as well as in symptomatic patients suspected of fifth disease (erythema infectiosum). It detects IgG antibodies in human serum, which indicate prior infection and immune response, aiding clinicians in confirming exposure or infection.
Is the ZEUS ELISA Parvovirus B19 IgG Test System intended for use outside of a clinical laboratory?
No, the test system is explicitly intended for use in a clinical laboratory setting only. It requires specialized equipment, trained personnel, and adherence to standard laboratory protocols for infectious disease testing, making it unsuitable for point-of-care or home use.
How is the ZEUS ELISA Parvovirus B19 IgG Test System supplied, and is it reusable?
The test system is supplied as a single-use in vitro diagnostic device, meaning each kit is designed for one test cycle only. This ensures accuracy and safety, as reuse could compromise sterility or introduce contamination, which is critical for reliable diagnostic results.
What regulatory approval does the ZEUS ELISA Parvovirus B19 IgG Test System hold, and how does this affect its use?
The test holds FDA Premarket Approval (PMA) under PMA number P150045, which confirms it meets stringent regulatory standards for diagnostic accuracy and safety. This approval ensures the test’s reliability for detecting IgG antibodies to parvovirus B19 in human serum, giving clinicians confidence in its results for clinical decision-making.
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 | P150045 | Class III | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA PMA P150045 24 fields · synced Sep 18, 2026