ANTI-HAV IGM— 510(k) K093955
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K093955 for ANTI-HAV IGM, Substantially Equivalent on 2010-06-22. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code LOL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3310
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LOL
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view allRecalls naming K093955
K-number listed on FDA's recall record- Z-0669-2020 — Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
- Z-0784-2019 — Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093955.
Data sourced from openFDA. This site is unofficial and independent of the FDA.