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.
DeviceDevice · Authorizations Verified Status Regime Registry Class
N Latex Rf Ref K942328
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINa Alpha 1 Microglobulin Kit Ref K904254
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Protein Standard Plasma (Human) Ref K880356
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Opus T3 Controls Ref K961206
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOpus Cmv Test System-Modification Ref K963084
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Control Plasma U Ref K924402
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Rapimat Ii Ref K861263
Active Regimes: 510(k) Registry: 510(k) ClassClass:ILaser Crp Kit(C-Reactive Protein Reagents) Ref K855057
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnaii Test Kit(Ss-A(Ro) & Ss-B(La) Autoantibody Ref K843978
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Coagulation Timer Ref K955278
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILaser Standard Serum Ref K761235
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISupplementary Reagents For Enzygnost/Tmb Ref K920416
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAft-Hep System Ref K860183
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus Tdm Controls Ref K954291
Active Regimes: 510(k) Registry: 510(k) ClassClass:IControl Plasma N Ref K924403
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus T3 Ref K953160
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Crp Standard Sy Ref K962406
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILaser Apo A-I Test Apolipoprotein A-I Reagents Ref K850638
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEnzygnost Lipase Test Ref K844240
Active Regimes: 510(k) Registry: 510(k) ClassClass:IClotting Factor V Deficient Plasma Ref K924394
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN/T Rheumatology Control Sl/1, Sl/2 Ref K944375
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIStandard Human Plasma Ref K924393
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBerichrom Alpha-2-Antiplasmin Ref K884797
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Turbitimer Ref K883646
Active Regimes: 510(k) Registry: 510(k) ClassClass:IN Latex Ige Kit (Immunoglobulin E Reagents) Ref K890530
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Antiserum To Human Transferrin Ref K972840
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus Ethanol Ref K972011
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINa Latex Myoglobin Test Ref K902154
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIControl Plasma P Ref K924405
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIClotting Factor-Viii-Ix-Xi-Xii Deficient Plasma Ref K924396
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRuba-Nost Test Kits Ref K771796
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIsotrak Amylase Test Amylase Isoenzyme Ref K853951
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIProtein C Reagent, Coagulometric Ref K924425
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMultitrol Immunology Control Ref K923663
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAntiserum Human (Pro.) Nephelometric Gr. Ref K761236
Active Regimes: 510(k) Registry: 510(k) ClassClass:IBc Thrombin Reagent Ref K970645
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRapitex (R) Crp New Ref K903853
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICellognost Syphilis H Ref K896410
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnzygnost Anti-Vzv Igg Test Ref K863317
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITurbiquant Ref K920124
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
N/T Protein Control Sy/L, M, And H Ref K941912
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOpus(R) Cea Test System Ref P920021
Active Regimes: PMA Registry: PMA ClassClass:II
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