Skip to content

Biokit USA, Inc.

Country not established

Devices
16
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Biokit USA, Inc. makes

Biokit USA, Inc. manufactures in vitro diagnostic reagents and test kits, including latex agglutination assays for rheumatoid factor (RF), antistreptolysin O (ASO), C-reactive protein (CRP), and rubella antibodies, as well as rapid plasma reagin (RPR) tests for syphilis detection and toxoplasma antibody screening.

These products are classified as Class I and Class II medical devices and are listed in the FDA’s 510(k) premarket notification database; the company is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

Search and filter all 16 devices
Skip device list

  • As Latex Plus Ref K842256

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

  • Rheumagen Aso T-Control Ref K904311

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

  • Rheumagen Crp T-Control Ref K904312

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

  • I.M.N. Latex Ref K874678

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

  • Rheumagen Rf T-Control Ref K904310

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

  • Modified Rubagen Ref K896433

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

  • Quantex Rf Plus (Latex, Buffer Standard, Control) Ref K896271

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

  • Toxogen Ref K913467

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

  • Rubagen Ref K893755

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

  • Rheumajet Crp Ref K910686

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

  • Biokit Rpr Ref K910541

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

  • Reumagen Asl Ref K854991

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

  • Rpr Test Reditest Ref K843741

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

  • Quantex Crp Plus (Latex, Buffer, Standard, Control Ref K896272

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

  • Quantex Aso Plus (Latex, Buffer Standard, Control) Ref K894486

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

  • Rheumajet Rf Ref K910539

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

Rows 1-16 of 16

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Biokit USA, Inc., initiated on 2010-04-14. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 14 Apr 2010 Z-1970-2010 Unclassified (pre-2012) Terminated Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. Distribution: US (CA, FL, GA, IN, KY, MA, NY, VA) and UK Submission number: K983886
    • 14 Apr 2010 Z-1971-2010 Unclassified (pre-2012) Terminated Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. Distribution: US (CA, FL, GA, IN, KY, MA, NY, VA) and UK Submission number: K983886

Frequently asked questions

How many devices does Biokit USA, Inc. have in the registry?

The registry currently lists 16 devices for Biokit USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biokit USA, Inc.'s devices?

Among its 16 most recently registered devices, Biokit USA, Inc. has devices listed in FDA 510(k) (16 devices).

What risk classes do Biokit USA, Inc.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Biokit USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Biokit USA, Inc.?

FDA recall records list 2 recalls initiated by Biokit USA, Inc., the most recent initiated on 14 Apr 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Biokit USA, Inc. in the registry?

The most recently registered devices listed for Biokit USA, Inc. include AS LATEX PLUS, RHEUMAGEN ASO T-CONTROL, RHEUMAGEN CRP T-CONTROL and I.M.N. LATEX.

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