Skip to content

Behring Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
146

What Behring Diagnostics, Inc. makes

Behring Diagnostics, Inc. manufactures clinical laboratory instrumentation and diagnostic testing products, including nephelometer systems, reagent kits, and various assay controls. Their product portfolio features calibration plasmas, enzyme-linked immunosorbent assays for viral detection, and specific protein testing reagents for rheumatology and cardiac markers.

The company is based in the United States, and its devices are categorized as Class I and Class II medical devices. These products are listed within the FDA 510(k) and FDA PMA regulatory registries.

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

Catalogue146

Newest first, rows 1-50 of 146

Search and filter all 146 devices
Skip device list

  • Clibration Plasmas Ref K924404

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

  • Opus Ck-Mb & Total Ck Controls Ref K960275

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

  • D.A.T. (Tm) Amylase Reagent Ref K871943

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

  • N/T Protein Control Sl Ref K964065

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

  • Enzygnost(R) Anti-Cmv Igg Ref K913910

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

  • N/T Rheumatology Control Sl/1 And Sl/2 Ref K962373

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

  • Behring Laser Nephelometer Ref K761234

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

  • Proc Apc Assay, Proc Control Plasma Ref K962968

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

  • Turbiquant Myoglobin Ref K905202

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

  • Turbiquant Immunoglobulin & Albumin Kit Ref K900167

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

  • Behring Nephelometer System Ref K860894

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

  • Ana Sensitivity/Specificity Control Ref K841776

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

  • Isotrak Amylase Isoenzyme Control Set Ref K861329

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

  • Von Willebrand Reagent Ref K972116

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

  • Immuno-Tec Ii Ot Agarose Plate Kit Ref K761270

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

  • Opus Psa Test System Ref K964595

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

  • Enzygnost + Anti-Cmv Igg Test Ref K852478

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

  • Opus Procainamide Ref K951434

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

  • Calcium Chloride/Diethylbarb Acetate Buff Solution Ref K924509

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

  • Modification Of Behring Rapimat Ii/T Ref K882095

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

  • Rapitex(R) Asl New Ref K903854

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

  • Opus B12 Ref K953455

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

  • Pathromtin Ref K932011

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

  • Behring Vector Photometer Ref K851098

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

  • Behring Fibrintimer A Ref K924124

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

  • Berichrom Antithrombin Iii (A) Ref K933125

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

  • N Protein Standars Sy Ref K955857

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

  • Laser Rf Test -Rheumatoid Factor(S) Reagents Ref K850296

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

  • Opus B12 Controls Ref K962694

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

  • Modification Of Opus Ferritin Test System Ref K973202

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

  • Enzygnost(R) Anti-Cmv/Igm Ref K913693

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

  • N Latex Ferritin Ref K950707

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

  • Test Thrombin Ref K930157

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

  • Enzygnost F 1+2 Ref K922934

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

  • Emit 2000 Gentamicin Assay And Calibrators Ref K962519

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

  • N Protein Standard Sy Ref K952594

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

  • Laser Ceruloplasmin Kit(Ceruloplasmin Reagents) Ref K852247

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

  • Thromborel S Ref K872844

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

  • N Latex Iga Ref K952309

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

  • N/T Protein Control Sy/L, M And H Ref K952593

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

  • Turbiquant Asl Ref K915742

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

  • Rapitex(R) Rf New Ref K903852

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

  • N/T Protein Control Sy/L, M And H Ref K955858

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

  • Pathromtin Sl Ref K955450

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

  • Pathoplasma(R) I & Ii (Path Citrated Human Plasma) Ref K924401

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

  • Opus Troponin I Ref K955284

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

  • N-Immunoglobulin Light Chain Kit Ref K880341

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

  • Emit Ii Opiates 300/2000 Assay Ref K971596

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

  • Enzygnost Anti-Cmv/Igg + Igm Ref K901485

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

  • N Latex Crp Mono Reagent Ref K962523

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

Rows 1-50 of 146

Showing 1-50 of 146

Frequently asked questions

How many devices does Behring Diagnostics, Inc. have in the registry?

The registry currently lists 146 devices for Behring Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Behring Diagnostics, Inc.'s devices?

Among its 50 most recently registered devices, Behring Diagnostics, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Behring Diagnostics, Inc.'s devices fall under?

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

What are the newest devices from Behring Diagnostics, Inc. in the registry?

The most recently registered devices listed for Behring Diagnostics, Inc. include CLIBRATION PLASMAS, OPUS CK-MB & TOTAL CK CONTROLS, D.A.T. (TM) AMYLASE REAGENT and N/T PROTEIN CONTROL SL.

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