Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
An enzyme-linked immunosorbent assay (ELISA) for varicella-zoster virus is a laboratory test that detects antibodies to the varicella-zoster virus in patient serum, used to assess immunity to chickenpox and shingles or to diagnose active infection. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFY and is regulated under 21 CFR 866.3900 within the Microbiology specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- LFY
- Device Class
- FDA class 2
- Regulation Number
- 866.3900
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | Oct 27, 2023 | Substantially Equivalent | DiaSorin Inc. |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | Mar 11, 2015 | Substantially Equivalent | DiaSorin Inc. |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Jul 05, 2007 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K061820 | DIASORIN LIAISON VZV IGG | Feb 26, 2007 | Substantially Equivalent | DIASORIN, INC. |
| K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | Dec 05, 2005 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K984181 | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM | Jan 22, 1999 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K981867 | IS-VZU IGG TEST SYSTEM | Sep 28, 1998 | Substantially Equivalent | DIAMEDIX CORP. |
| K972295 | SERAQUEST VZV IGG | Nov 05, 1997 | Substantially Equivalent | QUEST INTL., INC. |
| K961012 | VZV IGG ELISA TEST SYSTEM | Jul 24, 1996 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K943843 | VARICELISA, MODIFICATION | Mar 14, 1996 | Substantially Equivalent | BIOWHITTAKER MOLECULAR APPLICATIONS, INC. |
| K941046 | VZV IGG ELISA TEST | Aug 24, 1995 | Substantially Equivalent | GULL LABORATORIES, INC. |
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Oct 26, 1992 | Substantially Equivalent | BIOMERIEUX VITEK, INC. |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Jan 27, 1992 | Substantially Equivalent | PHARMACIA DIAGNOSTICS, INC. |
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | May 15, 1990 | Substantially Equivalent | CLINICAL SCIENCES, INC. |
| K890642 | VZV MICROASSAY | May 15, 1989 | Substantially Equivalent | DIAMEDIX CORP. |
| K833637 | VZV BIO-ENZABEAD SCREEN KIT | Feb 10, 1984 | Substantially Equivalent | BIONETIC LABORATORY PRODUCTS |
| K823805 | VARICELISA TEST KIT | May 05, 1983 | Substantially Equivalent | M.A. BIOPRODUCTS |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.