Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3900](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3900) → LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster # LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster _Microbiology · 21 CFR 866.3900 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY ## Overview - **Product Code:** LFY - **Device Name:** Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster - **Regulation:** [21 CFR 866.3900](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3900) - **Device Class:** 2 - **Review Panel:** [Microbiology](/submissions/MI) - **3rd-party reviewable:** yes ## Identification Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231214](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K231214.md) | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | Oct 27, 2023 | SESE | | [K150375](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K150375.md) | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | Mar 11, 2015 | SESE | | [K070317](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K070317.md) | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jul 5, 2007 | SESE | | [K061820](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K061820.md) | DIASORIN LIAISON VZV IGG | DiaSorin, Inc. | Feb 26, 2007 | SESE | | [K051484](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K051484.md) | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | Zeus Scientific, Inc. | Dec 5, 2005 | SESE | | [K984181](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K984181.md) | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jan 22, 1999 | SESE | | [K981867](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K981867.md) | IS-VZU IGG TEST SYSTEM | Diamedix Corp. | Sep 28, 1998 | SESE | | [K972295](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K972295.md) | SERAQUEST VZV IGG | Quest Intl., Inc. | Nov 5, 1997 | SESE | | [K961012](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K961012.md) | VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jul 24, 1996 | SESE | | [K943843](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K943843.md) | VARICELISA, MODIFICATION | Biowhittaker Molecular Applications, Inc. | Mar 14, 1996 | SESE | | [K941046](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K941046.md) | VZV IGG ELISA TEST | Gull Laboratories, Inc. | Aug 24, 1995 | SESE | | [K923122](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K923122.md) | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | Oct 26, 1992 | SESE | | [K914022](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K914022.md) | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Pharmacia Diagnostics, Inc. | Jan 27, 1992 | SESE | | [K900688](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K900688.md) | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | Clinical Sciences, Inc. | May 15, 1990 | SESE | | [K890642](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K890642.md) | VZV MICROASSAY | Diamedix Corp. | May 15, 1989 | SESE | | [K833637](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K833637.md) | VZV BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | Feb 10, 1984 | SESE | | [K823805](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY/K823805.md) | VARICELISA TEST KIT | M.A. Bioproducts | May 5, 1983 | SESE | ## Top Applicants - Zeus Scientific, Inc. — 4 clearances - DiaSorin, Inc. — 3 clearances - Diamedix Corp. — 2 clearances - Biomerieux Vitek, Inc. — 1 clearance - Bionetic Laboratory Products — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com