Product code LFY
- Device name
- Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3900
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | 2023-10-27 |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | 2015-03-11 |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2007-07-05 |
| K061820 | DIASORIN LIAISON VZV IGG | DiaSorin, Inc. | 2007-02-26 |
| K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | Zeus Scientific, Inc. | 2005-12-05 |
| K984181 | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-01-22 |
| K981867 | IS-VZU IGG TEST SYSTEM | Diamedix Corp. | 1998-09-28 |
| K972295 | SERAQUEST VZV IGG | Quest Intl., Inc. | 1997-11-05 |
| K961012 | VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1996-07-24 |
| K943843 | VARICELISA, MODIFICATION | Biowhittaker Molecular Applications, Inc. | 1996-03-14 |
| K941046 | VZV IGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-24 |
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-10-26 |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Pharmacia Diagnostics, Inc. | 1992-01-27 |
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | Clinical Sciences, Inc. | 1990-05-15 |
| K890642 | VZV MICROASSAY | Diamedix Corp. | 1989-05-15 |
| K833637 | VZV BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | 1984-02-10 |
| K823805 | VARICELISA TEST KIT | M.A. Bioproducts | 1983-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03573026644796 | VIDAS® Varicella-Zoster IgG | BIOMERIEUX SA | 2026-01-19 |
| 04048474028089 | Varicella Zoster Virus (VZV) IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239028082 | Varicella Zoster Virus (VZV) IgG ELISA | DRG International Inc | 2023-08-24 |
| B3507203800 | Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-05-20 |
| 05391516746830 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 05391516746793 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 05391516746755 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-26 |
| 05391516743532 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 00817273020228 | Diamedix | DIAMEDIX CORPORATION | 2016-09-20 |
| 00847865010979 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002332 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002189 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000758 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000727 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000734 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000765 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002264 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010757 | Bio-Rad Laboratories, Inc. | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00847865000741 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 03573026064518 | VIDAS® Varicella-Zoster IgG | BIOMERIEUX SA | 2016-08-31 |
| 00850487007012 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007340 | SeraQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00816057020584 | ASI VZV IgG EIA Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |