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- Last added
- 2026-10-17
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MONOLISA Anti-HAV IgM EIA EVOLIS Automated Microplate System 510(k) Decision Summary
The document describes the MONOLISA Anti-HAV IgM EIA, an in vitro enzyme immunoassay kit intended for the qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV) in human serum or plasma. It details the regulatory submission for a new indication involving the use of this assay with the EVOLIS Automated Microplate System.
Covers: 510(k) Number · Intended Use · Device Description · Substantial Equivalence Information · Test Principle · Performance Characteristics
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MONOLISA Anti-HAV IgM EIA EVOLIS Automated Microplate System 510(k) Decision Summary
Other 9 pages · 90 KB · ENThis document is a 510(k) Substantial Equivalence Determination Decision Summary for the MONOLISA Anti-HAV IgM EIA with the EVOLIS Automated Microplate System.
Questions answered in Bio-Rad Laboratories manuals
What types of human specimens are acceptable for this test?
The test is intended for use in human serum or plasma collected in EDTA, Heparin, Citrate, or ACD tubes.
From: MONOLISA Anti-HAV IgM EIA EVOLIS Automated Microplate System 510(k) Decision Summary
What is the required incubation time and temperature for the assay?
The assay requires a plate incubation of 60 ± 5 minutes at 37°C + 2°C.
From: MONOLISA Anti-HAV IgM EIA EVOLIS Automated Microplate System 510(k) Decision Summary