Zeus Scientific, Inc.
Zeus Scientific, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2022, with 4 FDA device recalls on record.
Top product codes for Zeus Scientific, Inc.
FDA recalls by Zeus Scientific, Inc.
- Z-0603-2024 — ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
- Z-0602-2024 — ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
- Z-3026-2020 — ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.
- Z-2494-2019 — Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Zeus Scientific, Inc.
1–100 of 135- K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
- K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
- K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
- K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM
- K102283 — ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
- K093784 — ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
- K100728 — ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
- K072178 — ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
- K071219 — ATHENA MULTI-LYTE GBM TEST SYSTEM
- K070317 — ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
- K063186 — ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
- K051484 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
- K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
- K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
- K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM
- K040111 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
- K033977 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
- K033802 — ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
- K021103 — MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
- K011244 — ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
- K001393 — THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
- K000879 — THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K000880 — THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K000362 — MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
- K000363 — MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K993250 — THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
- K991180 — BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
- K991185 — BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
- K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K991820 — HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
- K984180 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
- K991610 — ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
- K991179 — ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
- K983805 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K990204 — GLIADIN IGG ELISA TEST SYSTEM
- K990207 — GLIADIN IGA ELISA TEST SYSTEM
- K984138 — APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
- K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
- K984181 — THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
- K984317 — THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F
- K984170 — THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
- K984123 — THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
- K984126 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K984139 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
- K984516 — THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
- K984173 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
- K984175 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
- K984315 — THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
- K984347 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
- K983803 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983801 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K983804 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K984034 — THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K983376 — THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
- K983378 — THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
- K983418 — THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
- K983420 — THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
- K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
- K983423 — THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983425 — THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
- K983426 — THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC
- K983464 — THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K981120 — ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
- K980821 — HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
- K981014 — ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
- K981021 — ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
- K981020 — ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
- K973196 — ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
- K971503 — MYCOPLASMA IGM ELISA TEST SYSTEM
- K971784 — ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
- K970149 — LEGIONELLA ELISA TEST SYSTEM
- K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM
- K964446 — MYELOPEROXIDASE ELISA TEST SYSTEM
- K964448 — PROTEINASE-3 IGG ELISA TEST SYSTEM
- K964449 — ANCA SCREEN ELISA TEST SYSTEM
- K961012 — VZV IGG ELISA TEST SYSTEM
- K961204 — MUMPS IGG TEST
- K961277 — RF IGM ELISA TEST SYSTEM
- K946373 — MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM
- K944449 — EBV-VCA IGM ELISA TEST STSTEM
- K944417 — ZEUA MYCOPLASMA
- K932742 — EBNA IGG ELISA TEST SYSTEM
- K940362 — ANA SCREEN ELISA TEST SYSTEM
- K941014 — ENA SCREEN ELISA TEST SYSTEM
- K941409 — ENA PROFILE-6 ELISA TEST SYSTEM
- K933267 — AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
- K924096 — CMV ELISA TEST SYSTEM
- K924882 — TOXOPLASMA IGM IFA TEST SYSTEM
- K924091 — EBV-VCA IGG ELISA TEST SYSTEM
- K924197 — ZORBA(TM) IGG REMOVAL REAGENT
- K914028 — RUBELLA IGM ELISA TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.