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Elias U.S.A., Inc.

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Devices
54

What Elias U.S.A., Inc. makes

Elias U.S.A., Inc. manufactures a range of diagnostic test kits and microtiter plate assays for the detection of antibodies and proteins. Their product portfolio includes tests for autoimmune markers such as ANA, ENA, PR3-ANCA, SCL-70, and M2-antibodies, as well as assays for Helicobacter pylori, cardiolipin, and microalbumin.

The company is based in the United States and maintains a portfolio of Class I and Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue54

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  • Elias Ena Screen (Microtiter Plate) Ref K940622

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Helicobacter Pylori Antibodies Ref K953873

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Varelisa Combined Dna Antibodies Eia Ref K944334

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Tgab/Tmab Ref K915135

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Cardiolipin Antibodies Ref K924421

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Syn Elisa Micro Albumin Ref K920216

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Varelisa PR3-Anca Ref K953586

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Aynelisa M2-Antibodies Ref K930143

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Syn Elisa Beta 2 Microglobulin Test Kit Ref K920132

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Ana Total Ref K940641

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Syn Ena Screen (Pin Plate) Ref K940229

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Scl-70 Antibodies Ref K944172

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa M2 Antibodies Ref K945607

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Dhea-Sulfate Ref K935469

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Varelisa Rnp-Sm Antibodies Ref K944167

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Ana-4 Screen Ref K951186

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Centromere Antibodies Ref K944171

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa U1-Snrnp (68KDA)-Antibodies Ref K930142

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Cardiolipin Antibodies Ref K935288

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Cardiolipin Antibodies Ref K921250

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Tmab Ref K915133

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Mpo-Anca Ref K953587

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Histone Antibodies Ref K951207

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Parietal Cell Antibodies Ref K951206

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Cardiolipin Antibodies Ref K940403

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Cenp-B Antibodies Ref K931255

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Tpo Antibodies Ref K921787

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa La (Ss-B) Antibodies Ref K944168

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Sm Abs/Rnp-Sm Abs Ref K930141

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Ana-Hep-2 Ref K964385

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Tmab Ref K925923

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Jo-1 Antibodies Ref K930281

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Tg Antibodies/Tpo Antibodies Ref K933123

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Varelisa Sm Antibodies Ref K944170

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Ro Abs / La Abs Ref K930209

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Cortisol Ref K931177

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Dsdna Antibodies (Farr Version) Ref K950031

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Ana Profile Ref K951205

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Tgab Ref K915134

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Cardiolipin Igg Antibodies Ref K933393

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Ana (4) Profile Ref K963291

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Parietal Cell Antibodies Ref K930422

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Cardiolipin Abs Screen Ref K951187

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sylnelisa Histone Antibodies Ref K932302

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Ana Total Ref K935468

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Tgab Ref K925922

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Varelisa Ro (Ss-A) Antibodies Ref K944169

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Dsdna Abs Ref K930421

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Synelisa Ana Profile Ref K932206

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Elias Cardiolipin Igm Antibodies Ref K933392

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 54

Showing 1-50 of 54

Frequently asked questions

How many devices does Elias U.S.A., Inc. have in the registry?

The registry currently lists 54 devices for Elias U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Elias U.S.A., Inc.'s devices?

Among its 50 most recently registered devices, Elias U.S.A., Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Elias U.S.A., Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Elias U.S.A., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Elias U.S.A., Inc. in the registry?

The most recently registered devices listed for Elias U.S.A., Inc. include ELIAS ENA SCREEN (MICROTITER PLATE), VARELISA HELICOBACTER PYLORI ANTIBODIES, VARELISA COMBINED DNA ANTIBODIES EIA and SYNELISA TGAB/TMAB.

Generated automatically from registry data and not verified by a human reviewer.