Zeus ELISA Parvovirus B19 IgM Test System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM FDA PMA
- Generic Name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM FDA PMA
Identifiers
- PMA Number
- P150042 FDA PMA
- FDA Product Code
- MYM 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 IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to human parvovirus B19 in human serum. It is classified as a Class III in vitro diagnostic device and is intended for identifying 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 reagent kit for laboratory use and requires no sterilisation beyond manufacturer-provided precautions. It is intended for single-use per test and must be stored and handled according to the accompanying instructions. Authorised under FDA_PMA (PMA Number: P150042), it adheres to regulatory standards for microbiological assays and is filed under advisory committee MI (Microbiology).
Frequently asked questions
What is the primary clinical purpose of the Zeus ELISA Parvovirus B19 IgM Test System, and who is it most commonly used for?
The test is designed for the qualitative detection of IgM antibodies to parvovirus B19 in human serum, helping identify recent exposure to the virus. It is particularly recommended for women of childbearing age, as parvovirus B19 infection during pregnancy can pose risks to fetal health, and for symptomatic patients suspected of fifth disease (erythema infectiosum). The system aids in diagnosing parvovirus B19 infections by confirming IgM presence, which indicates acute or recent infection.
How is the Zeus ELISA Parvovirus B19 IgM Test System supplied, and is it intended for single-use or reusable applications?
The test system is supplied as an in vitro diagnostic reagent kit for laboratory use. It is explicitly intended for **single-use per test**, meaning each kit is designed for one use only. Proper storage and handling per the manufacturer’s instructions are required to maintain accuracy and reliability, as reuse is not supported or validated by the manufacturer.
Does this test require any special sterilization procedures, and how should it be stored?
The test system does not require sterilization beyond the precautions provided by the manufacturer. It is intended for laboratory use, and storage must follow the accompanying instructions to preserve its integrity. Since it is a reagent kit, it should be stored in a controlled environment to prevent contamination or degradation, such as at room temperature or refrigerated conditions as specified in the documentation.
What regulatory pathway was followed for the approval of the Zeus ELISA Parvovirus B19 IgM Test System, and what does this mean for its use?
The test was approved under the **FDA Pre-Market Approval (PMA) pathway**, specifically with PMA Number **P150042**. This pathway is typically used for high-risk Class III devices, ensuring rigorous evaluation of safety and effectiveness. Clinically, this means the test has undergone thorough validation for its intended use—qualitative detection of parvovirus B19 IgM antibodies in human serum—and meets stringent regulatory standards for diagnostic accuracy and reliability.
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 | P150042 | Class III | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA PMA P150042 24 fields · synced Sep 18, 2026