LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Microbiology · 21 CFR 866.3900 · Class 2
Overview
| Product Code | LFY |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster |
| Regulation | 21 CFR 866.3900 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 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 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | Oct 27, 2023 | SESE |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | Mar 11, 2015 | SESE |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jul 5, 2007 | SESE |
| K061820 | DIASORIN LIAISON VZV IGG | DiaSorin, Inc. | Feb 26, 2007 | SESE |
| K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | Zeus Scientific, Inc. | Dec 5, 2005 | SESE |
| K984181 | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jan 22, 1999 | SESE |
| K981867 | IS-VZU IGG TEST SYSTEM | Diamedix Corp. | Sep 28, 1998 | SESE |
| K972295 | SERAQUEST VZV IGG | Quest Intl., Inc. | Nov 5, 1997 | SESE |
| K961012 | VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jul 24, 1996 | SESE |
| K943843 | VARICELISA, MODIFICATION | Biowhittaker Molecular Applications, Inc. | Mar 14, 1996 | SESE |
| K941046 | VZV IGG ELISA TEST | Gull Laboratories, Inc. | Aug 24, 1995 | SESE |
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | Oct 26, 1992 | SESE |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Pharmacia Diagnostics, Inc. | Jan 27, 1992 | SESE |
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | Clinical Sciences, Inc. | May 15, 1990 | SESE |
| K890642 | VZV MICROASSAY | Diamedix Corp. | May 15, 1989 | SESE |
| K833637 | VZV BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | Feb 10, 1984 | SESE |
| K823805 | 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
