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Zeus Scientific, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
140
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0603-2024Class IIZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701GOctober 31, 2023
Z-0602-2024Class IIZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701MOctober 31, 2023
Z-3026-2020Class IIZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualAugust 12, 2019
Z-2494-2019Class IIDynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgJuly 22, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K250666Alegria Flash CTD ScreenOctober 22, 2025
K250408Alegria Flash ENA ScreenSeptember 19, 2025
K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (FormMay 7, 2025
K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineAugust 31, 2023
K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM CJuly 13, 2023
K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineApril 29, 2022
K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SJuly 29, 2019
K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SysteJuly 29, 2019
K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SysteJuly 29, 2019
K113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMJuly 26, 2012
K102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEMDecember 12, 2011
K103603ZEUS ELISA HSV GG-2 IGG TEST SYSTEMMay 20, 2011
K103363ZEUS ELISA HSV GC-I IGG TEST SYSTEMApril 26, 2011
K102283ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEMFebruary 10, 2011
K093784ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEMJuly 16, 2010
K100728ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEMJuly 6, 2010
K072178ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEMMay 30, 2008
K071219ATHENA MULTI-LYTE GBM TEST SYSTEMDecember 6, 2007
K070317ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEMJuly 5, 2007
K063186ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEMMarch 21, 2007