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Micro Detect, Inc.

United StatesFDA applicant, unverified FDA FEI 3001697474

Devices
11
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Micro Detect, Inc. makes

Micro Detect, Inc. manufactures serology-based diagnostic tests, including ELISA assays and enzyme immunoassays for detecting specific autoantibodies in human serum. Their portfolio covers tests for systemic sclerosis markers (e.g., SS-A, SS-B, SCL-70, SM/RNP), rheumatoid factor (RF), anti-dsDNA antibodies, and celiac disease markers (gliadin A and gliadin G). Additional offerings include serological tests for *Helicobacter pylori* IgG antibodies.

The company’s devices are regulated under FDA’s Class I and Class II categories, with submissions recorded via the 510(k) pathway. Their products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Elisa Test, Serology Ref K003794

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

  • Mdi Sm/Rnp Test Ref K993635

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

  • Mdi Ss-B Test Enzyme Immunoassay For The Detection Of Autoantibodies To Ss-B In Human Serum Ref K993971

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

  • Mdi Rf Test Ref K993843

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

  • Mdi Gliadin G Test Ref K002359

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

  • Mdi Gliadin A Test Ref K002358

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

  • Pylori Detect Igg Ref K973508

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

  • Mdi Ds-Dna Test Ref K000477

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

  • Mdi Scl-70 Test Ref K000934

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

  • Mdi Ss-A Test Ref K993636

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

  • Mdi Sm Test Ref K994029

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

Rows 1-11 of 11

Company details

FDA FEI number
3001697474
Address
2852 WALNUT AVE., SUITE H-1, TUSTIN, CA, 92780

Frequently asked questions

How many devices does Micro Detect, Inc. have in the registry?

The registry currently lists 11 devices for Micro Detect, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Micro Detect, Inc.'s devices?

Among its 11 most recently registered devices, Micro Detect, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Micro Detect, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Micro Detect, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Micro Detect, Inc. in the registry?

The most recently registered devices listed for Micro Detect, Inc. include ELISA TEST, SEROLOGY, MDI SM/RNP TEST, MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM and MDI RF TEST.

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