LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Class II
FDA product code LFY covers "Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster", a Class II medical device regulated under 21 CFR 866.3900. Submissions are reviewed by the Microbiology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LFY
- Device Class
- Class II
- Regulation Number
- 866.3900
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231214 | diasorin | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | October 27, 2023 |
| K150375 | diasorin | LIAISON VZV IgG, LIAISON Control VZV IgG | March 11, 2015 |
| K070317 | zeus scientific | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | July 5, 2007 |
| K061820 | diasorin | DIASORIN LIAISON VZV IGG | February 26, 2007 |
| K051484 | zeus scientific | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | December 5, 2005 |
| K984181 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM | January 22, 1999 |
| K981867 | diamedix | IS-VZU IGG TEST SYSTEM | September 28, 1998 |
| K972295 | quest intl | SERAQUEST VZV IGG | November 5, 1997 |
| K961012 | zeus scientific | VZV IGG ELISA TEST SYSTEM | July 24, 1996 |
| K943843 | biowhittaker molecular applications | VARICELISA, MODIFICATION | March 14, 1996 |
| K941046 | gull laboratories | VZV IGG ELISA TEST | August 24, 1995 |
| K923122 | biomerieux vitek | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | October 26, 1992 |
| K914022 | pharmacia diagnostics | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | January 27, 1992 |
| K900688 | clinical sciences | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | May 15, 1990 |
| K890642 | diamedix | VZV MICROASSAY | May 15, 1989 |
| K833637 | bionetic laboratory products | VZV BIO-ENZABEAD SCREEN KIT | February 10, 1984 |
| K823805 | m.a. bioproducts | VARICELISA TEST KIT | May 5, 1983 |