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Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
FDA product code LFY · Class 2 · Microbiology
23
Registered devices
31
Adverse events
4
Recalls
17
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.Diamedix — DIAMEDIX CORPORATIONSeraQuest — QUEST INTERNATIONAL, INC.VIDAS® Varicella-Zoster IgG — BIOMERIEUX SAVaricella Zoster Virus (VZV) IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.Trinity Biotech — CLARK LABORATORIES, INC.ASI VZV IgG EIA Test — ARLINGTON SCIENTIFIC, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Varicella Zoster Virus (VZV) IgG ELISA — DRG International IncTrinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.ReQuest — QUEST INTERNATIONAL, INC.Trinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.VIDAS® Varicella-Zoster IgG — BIOMERIEUX SABioPlex 2200 — BIO-RAD LABORATORIES, INC.Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit — Gold Standard Diagnostics Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2019-12-10 | bioMerieux, Inc. | Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration ma |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2003-09-10 | Diasorin Inc. | Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results. |
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