Zeus Scientific LLC
Branchburg, NJ, US
ZEUS SCIENTIFIC LLC appears in FDA device records in Branchburg, NJ. FDA records list 141 510(k) clearances between and , 5 PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 141FDA records hold 141 510(k) clearances for Zeus Scientific LLC between 1976 and 2026. The busiest year on record is 1999, with 24. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1978 | 5 |
| 1979 | 1 |
| 1981 | 4 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 7 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 4 |
| 1997 | 8 |
| 1998 | 23 |
| 1999 | 24 |
| 2000 | 5 |
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 4 |
| 2005 | 3 |
| 2007 | 3 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 1 |
| 2019 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | OBE | Substantially Equivalent | |
| K250666 | Alegria Flash CTD Screen | LLL | Substantially Equivalent | |
| K250408 | Alegria Flash ENA Screen | LLL | Substantially Equivalent | |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | MOB | Substantially Equivalent | |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | KTL | Substantially Equivalent | |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | LSR | Substantially Equivalent | |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | DHN | Substantially Equivalent | |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | LSR | Substantially Equivalent | |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | LSR | Substantially Equivalent | |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | LSR | Substantially Equivalent | |
| K113397 | ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM | LSR | Substantially Equivalent | |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | MID | Substantially Equivalent | |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | MYF | Substantially Equivalent | |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | MXJ | Substantially Equivalent | |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | LIP | Substantially Equivalent | |
| K093784 | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM | OPM | Substantially Equivalent | |
| K100728 | ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM | LSR | Substantially Equivalent | |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | MXJ | Substantially Equivalent | |
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | MVJ | Substantially Equivalent | |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | LFY | Substantially Equivalent | |
| K063186 | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM | LFX | Substantially Equivalent | |
| K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | LFY | Substantially Equivalent | |
| K042118 | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | JRY | Substantially Equivalent | |
| K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | LJN | Substantially Equivalent | |
| K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM | LKJ | Substantially Equivalent | |
| K040111 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM | MOB | Substantially Equivalent | |
| K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | JZO | Substantially Equivalent | |
| K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | DHR | Substantially Equivalent | |
| K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM | LKJ | Substantially Equivalent | |
| K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM | LKJ | Substantially Equivalent | |
| K001393 | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR | MST | Substantially Equivalent | |
| K000880 | THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | LJM | Substantially Equivalent | |
| K000879 | THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | LJM | Substantially Equivalent | |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | DDC | Substantially Equivalent | |
| K000362 | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM | JZO | Substantially Equivalent | |
| K993250 | THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. | MST | Substantially Equivalent | |
| K992166 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | LGC | Substantially Equivalent | |
| K991185 | BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM | LSR | Substantially Equivalent | |
| K991180 | BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM | LSR | Substantially Equivalent | |
| K991820 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI | LYR | Substantially Equivalent | |
| K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM | LFX | Substantially Equivalent | |
| K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | DDC | Substantially Equivalent | |
| K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | DDC | Substantially Equivalent | |
| K984135 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | GQL | Substantially Equivalent | |
| K984120 | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | GQL | Substantially Equivalent | |
| K983805 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO | LFX | Substantially Equivalent | |
| K990207 | GLIADIN IGA ELISA TEST SYSTEM | MST | Substantially Equivalent | |
| K990204 | GLIADIN IGG ELISA TEST SYSTEM | MST | Substantially Equivalent | |
| K984138 | APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM | LSR | Substantially Equivalent | |
| K983656 | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM | LGC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2242436 | 2242436 | ZEUS SCIENTIFIC LLC | 200 EVANS WAY, BRANCHBURG, NJ 08876 US | 2026 | and 51 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- GMSAnti-Human Globulin, Fta-Abs Test
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- MSTAntibodies, Gliadin
- LJNAntibody Igm, If, Epstein-Barr Virus
- LKQAntibody Igm,If, Cytomegalovirus Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
- MCDAntigen, Ebv, Capsid
- GLZAntigens, If, Toxoplasma Gondii
- GMQAntigens, Nontreponemal, All
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- DBJAntiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee
- GMPAntisera, Control For Nontreponemal Tests
- GRZAntisera, Fluorescent, All, Mycoplasma Spp.
- LKIAntisera, Fluorescent, Chlamydia Spp.
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- KIYChamber, Slide Culture
- JMMColumn Chromatography & Color Development, Hydroxyproline
- DAKComplement C1q, Antigen, Antiserum, Control
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- LDZFixative, Alcohol Containing
- LYRHelicobacter Pylori
- DEWIgg, Antigen, Antiserum, Control
- LPIKit, Assay, Progesterone Receptor
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- LSRReagent, Borrelia Serological Reagent
- LSQReagent, Rickettsia Serological
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent
- MIDSystem, Test, Anticardiolipin Immunological
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
- DDCThyroglobulin, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0603-2024 | ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G | The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation. | Class II | Open, Classified | |
| Z-0602-2024 | ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M | The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation. | Class II | Open, Classified | |
| 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. | FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer. | Class II | Terminated | |
| 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 | Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6. | Class II | Terminated | |
| Z-1500-2012 | AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus. | Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps. | Terminated | ||
| Z-1089-2009 | Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. Also manufactured for Wampole Laboratories, Princeton, NJ 08540 Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use. | The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266. | Terminated | ||
| Z-0214-05 | Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box. | During packaging, Lyme plates were packaged in this kit in error. | Terminated | ||
| Z-1095-03 | Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ. | The Calibrator included within the kit may be losing reactivity. | Terminated | ||
| Z-1031-03 | Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ. | Calibrator C not meeting its optical density specification. | Terminated | ||
| Z-1147-03 | Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO. | Bacterial contamination of the high positive control. | Terminated | ||
| Z-0961-03 | Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055 | Mix-up between low positive and negative controls. | Terminated | ||
| Z-1065-03 | Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B | The high positive control/low positive standard ratio recovering too low. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain