Elias U.S.A., Inc.
Medical device manufacturer in Osceola, WI.
54510(k) clearances
0PMA approvals
0recalls
Device types
- LJM Antinuclear Antibody (Enzyme-Labeled)… 16
- MID System, Test, Anticardiolipin Immunological 7
- JZO System, Test, Thyroid Autoantibody 5
- LLL Extractable Antinuclear Antibody, Antigen… 4
- LKJ Antinuclear Antibody, Antigen, Control 3
- DBM Antimitochondrial Antibody, Indirect… 2
- MOB Test System, Antineutrophil Cytoplasmic… 2
- LRM Anti-Dna Antibody (Enzyme-Labeled)… 2
- LKP Anti-Sm Antibody, Antigen And Control 1
- LKO Anti-Rnp Antibody, Antigen And Control 1
- JIR Indicator Method, Protein Or Albumin… 1
- DHC System, Test, Systemic Lupus Erythematosus 1
- DBJ Antiparietal Antibody, Indirect… 1
- JZS Electrophoresis Instrumentation 1
- CGR Radioimmunoassay, Cortisol 1
- JLS Radioimmunoassay, Progesterone 1
- JKC Radioimmunoassay, Dehydroepiandrosterone… 1
- JNL Immunochemical, Thyroglobulin Autoantibody 1
- MLE Enzyme Immunoassay, Antiparietal Cell… 1
- JZG System, Test, Beta-2-Microglobulin… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K964385 | Elias ANA-HEP-2LJM · Traditional | 03/06/1997SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | 09/30/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
| K944334 | Varelisa Combined DNA Antibodies EiaLRM · Traditional | 04/17/1995SE |
| K950031 | Varelisa Dsdna Antibodies (Farr Version)LRM · Traditional | 03/10/1995SE |
| K945607 | Varelisa M2 AntibodiesDBM · Traditional | 01/24/1995SE |
| K944173 | Varelisa JO-1 AntibodiesLJM · Traditional | 12/22/1994SE |
| K944172 | Varelisa SCL-70 AntibodiesLJM · Traditional | 12/22/1994SE |
| K944171 | Varelisa Centromere AntibodiesLJM · Traditional | 12/22/1994SE |
| K944170 | Varelisa SM AntibodiesLJM · Traditional | 12/22/1994SE |
| K944169 | Varelisa Ro (Ss-A) AntibodiesLJM · Traditional | 12/22/1994SE |
| K944168 | Varelisa la (Ss-B) AntibodiesLJM · Traditional | 12/22/1994SE |
| K944167 | Varelisa Rnp-Sm AntibodiesLJM · Traditional | 12/22/1994SE |
| K940403 | Elias Cardiolipin AntibodiesMID · Traditional | 09/20/1994SE |
| K940622 | Elias Ena Screen (Microtiter Plate)LLL · Traditional | 05/11/1994SE |
| K940229 | Syn Ena Screen (Pin Plate)LLL · Traditional | 05/11/1994SE |
| K940641 | Elias Ana TotalLJM · Traditional | 03/25/1994SE |
| K935468 | Synelisa Ana TotalLJM · Traditional | 03/25/1994SE |
| K935469 | Synelisa Dhea-SulfateJKC · Traditional | 03/22/1994SE |
| K935288 | Synelisa Cardiolipin AntibodiesMID · Traditional | 01/24/1994SE |
| K933393 | Elias Cardiolipin Igg AntibodiesMID · Traditional | 12/08/1993SE |
| K933392 | Elias Cardiolipin Igm AntibodiesMID · Traditional | 12/08/1993SE |
| K932206 | Synelisa Ana ProfileLJM · Traditional | 12/03/1993SE |
| K933128 | Synelisa ProgesteroneJLS · Traditional | 11/05/1993SE |
| K931177 | Synelisa CortisolCGR · Traditional | 09/27/1993SE |
| K931255 | Synelisa Cenp-B AntibodiesLKJ · Traditional | 09/24/1993SE |
| K933123 | Synelisa TG Antibodies/Tpo AntibodiesJZS · Traditional | 08/23/1993SE |
| K932302 | Sylnelisa Histone AntibodiesLKJ · Traditional | 08/23/1993SE |
| K930422 | Synelisa Parietal Cell AntibodiesDBJ · Traditional | 08/03/1993SE |
| K930209 | Synelisa Ro Abs / la AbsLJM · Traditional | 06/11/1993SE |
| K930143 | Aynelisa M2-ANTIBODIESDBM · Traditional | 05/11/1993SE |
| K930142 | Synelisa U1-SNRNP (68KDA)-ANTIBODIESLKO · Traditional | 05/11/1993SE |
| K930141 | Synelisa SM Abs/Rnp-Sm AbsLKP · Traditional | 05/11/1993SE |
| K930417 | Synelisa SCL-70 AntibodiesLLL · Traditional | 04/06/1993SE |
| K930281 | Synelisa JO-1 AntibodiesLLL · Traditional | 04/06/1993SE |
| K930421 | Elias Dsdna AbsDHC · Traditional | 03/10/1993SE |
| K925923 | Elias TmabJZO · Traditional | 01/14/1993SE |
| K925922 | Elias TgabJZO · Traditional | 01/14/1993SE |
| K921132 | Syn Elisa Dsdna AntibodiesLKJ · Traditional | 12/01/1992SE |
| K924421 | Synelisa Cardiolipin AntibodiesMID · Traditional | 11/30/1992SE |
| K921787 | Synelisa Tpo AntibodiesJNL · Traditional | 07/28/1992SE |
| K921250 | Synelisa Cardiolipin AntibodiesMID · Traditional | 06/04/1992SE |
| K920132 | Syn Elisa Beta 2 Microglobulin Test KitJZG · Traditional | 05/28/1992SE |
| K915135 | Synelisa Tgab/TmabJZO · Traditional | 04/08/1992SE |
| K915134 | Synelisa TgabJZO · Traditional | 04/08/1992SE |
| K915133 | Synelisa TmabJZO · Traditional | 04/08/1992SE |
| K920216 | Syn Elisa Micro AlbuminJIR · Traditional | 03/11/1992SE |