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Culture Kits, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
9

What Culture Kits, Inc. makes

Culture Kits, Inc. produces diagnostic culture kits for microbiological testing, including DERM-KIT for skin infections, CANDI-KIT™ for fungal cultures, and URINE DUO for urinary tract analysis. Their portfolio also covers STREP-KIT and STAPH KIT for bacterial identification, GONI-KIT for gonorrhea detection, and URI-KIT/URI-THREE™ for respiratory pathogen testing. The company offers Mueller Hinton Sensitivity Plates for antimicrobial susceptibility testing.

The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These kits are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Derm-Kit Ref K852480

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

  • Candi-Kit Tm Ref K854672

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

  • Urine Duo Ref K851225

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

  • Strep-Kit Ref K850765

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

  • Staph Kit Ref K853488

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

  • Goni-Kit Ref K852582

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

  • Uri-Three(Tm), Modification Ref K911846

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

  • Mueller Hinton Sensitivity Plate Ref K851518

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

  • Uri-Kit Ref K850998

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

Frequently asked questions

How many devices does Culture Kits, Inc. have in the registry?

The registry currently lists 9 devices for Culture Kits, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Culture Kits, Inc.'s devices?

Among its 9 most recently registered devices, Culture Kits, Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Culture Kits, Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Culture Kits, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Culture Kits, Inc. in the registry?

The most recently registered devices listed for Culture Kits, Inc. include DERM-KIT, CANDI-KIT TM, URINE DUO and STREP-KIT.

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