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Orion Corp.

Country not established FDA

Devices
21
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Orion Corp. makes

Orion Corp. manufactures diagnostic assays and microbiological culture devices, including immunochemical tests for apolipoproteins (A1 and B), chlamydia antibodies, and microalbuminuria. Their portfolio also includes culture media like the Oricult-N and Dentocult products for detecting bacterial strains, as well as a dental plaque analysis device (Mamex DC). They produce both single-use and revised versions of certain assays, such as the Rubalex test.

The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. Their offerings are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Orion Corp. operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

Newest first, rows 1-21 of 21

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  • Rubalex Ref K852788

    Class II
    Active 510(k) 510(k) II

  • Microalbuminuria Assay Ref K862671

    Class II
    Active 510(k) 510(k) II

  • Oricult-N Culture-Paddle Ref K872058

    Class I
    Active 510(k) 510(k) I

  • Immunochemical Assay Apolipoprotein B Ref K861882

    Class I
    Active 510(k) 510(k) I

  • Chlamyset Antibody Eia Ref K864457

    Class I
    Active 510(k) 510(k) I

  • Mamex Dc Mag MG12 Ref K881506

    Class II
    Active 510(k) 510(k) II

  • Resubmitted Scanora Ref K884650

    Class II
    Active 510(k) 510(k) II

  • Dentocult Culture-Paddle Ref K851164

    Class I
    Active 510(k) 510(k) I

  • Myolex Ref K863730

    Class II
    Active 510(k) 510(k) II

  • Immunochemical Assay Of Apolipoprotein A1 Ref K861883

    Class I
    Active 510(k) 510(k) I

  • Dentocult Sm-Strip Mutans Ref K890199

    Class I
    Active 510(k) 510(k) I

  • Rubalex (Revised Version) Ref K861881

    Class II
    Active 510(k) 510(k) II

  • Chlamyset Antigen Ref K853401

    Class I
    Active 510(k) 510(k) I

  • Resubmitted Modified Rubalex Ref K901637

    Class II
    Active 510(k) 510(k) II

  • Dentocult-Sm Culture-Paddle Ref K872301

    Class I
    Active 510(k) 510(k) I

  • Rubalex, Modification Ref K912391

    Class II
    Active 510(k) 510(k) II

  • Modified Chlamyset Antigen Ref K872744

    Class I
    Active 510(k) 510(k) I

  • Mamex Dc S SL10/MG14 Ref K874040

    Class II
    Active 510(k) 510(k) II

  • Rotalex Ref K860529

    Class I
    Active 510(k) 510(k) I

  • Immunochemical Assay Of C-Reactive Protein Ref K860679

    Class II
    Active 510(k) 510(k) II

  • Mamex Dc MG11 Ref K881505

    Class II
    Active 510(k) 510(k) II

Rows 1-21 of 21

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • Orion SRL IT
  • Orion Corporation FI

Frequently asked questions

How many devices does Orion Corp. have in the registry?

The registry currently lists 21 devices for Orion Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orion Corp.'s devices?

Among its 21 most recently registered devices, Orion Corp. has devices listed in FDA 510(k) (21 devices).

What risk classes do Orion Corp.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for Orion Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Orion Corp. in the registry?

The most recently registered devices listed for Orion Corp. include RUBALEX, MICROALBUMINURIA ASSAY, ORICULT-N CULTURE-PADDLE and IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B.

Which FDA establishments are linked to Orion Corp.?

2 FDA establishments are linked to Orion Corp. in the registry; they are listed on the company page.

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