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/T Protein Control Py Ref K951012
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMultifibren Ref K925988
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN/T Protein Control Py Ref K962407
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIClotting Factor-11, -Vii, -X Deficient Plasma Ref K924400
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Nephelometer 100 Ref K892223
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOpus Hlh Ref K962866
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITurbiquant Myoglobin Ref K903687
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnzygnost Rotavirus AG Ref K841243
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEnzygnost Beta-2 Microglobulin Test Ref K843967
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus D-Dimer Ref K972316
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Nephelometer Ii Ref K943997
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Latex Crp Mono Reagent Ref K964687
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnzygnost(R) Tat Reagents Ref K880700
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Rheumatology Standard Sl Ref K964527
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Coagulation System Ref K970431
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINeothromitin(R) Ref K924395
Active Regimes: 510(k) Registry: 510(k) ClassClass:IN Latex B2-Microglobulin Reagent Ref K955596
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAft(R) Hep Performance Evaluation Program Ref K865019
Active Regimes: 510(k) Registry: 510(k) ClassClass:—Ena Iii Test Kit (Scl-70 Autoantibody Reagents) Ref K871994
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Antiserum To C1 Inhibitor Ref K960257
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus Progesterone Ref K971725
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOpus Prolactin Controls Ref K955468
Active Regimes: 510(k) Registry: 510(k) ClassClass:ILaser Rf Control Serum-Quality Control Serum Ref K851537
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBatroxobin Reagent Ref K932787
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBerichrom(R) Plasminogen Ref K884766
Active Regimes: 510(k) Registry: 510(k) ClassClass:IN/T Protein Control Uy Ref K914890
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEnzygnost Toxoplasmosis/Igm Ref K913505
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus Hlh Controls Ref K973832
Active Regimes: 510(k) Registry: 510(k) ClassClass:IN Antiserum To Human Albumin Ref K972929
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIN Protein Strandard Sl Ref K964062
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnzygnost(R) Toxoplasmosis/Igg Ref K913731
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMultifibren U Ref K934326
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnzygnost Anti-Cmv Igg Test Ref K863488
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILaser Prealbumin Test Ref K851912
Active Regimes: 510(k) Registry: 510(k) ClassClass:IBerichrom Protein C Kit Ref K890634
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILaser Aso Kit Ref K854039
Active Regimes: 510(k) Registry: 510(k) ClassClass:IBehring Fibrintimer A Ref K926551
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEnzygnost Antiherpes Simplex Virus Ref K841245
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus Myoglobin Controls Ref K962841
Active Regimes: 510(k) Registry: 510(k) ClassClass:IOpus Hcg Controls Ref K954144
Active Regimes: 510(k) Registry: 510(k) ClassClass:IBehring Chromotimer Ref K901829
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEnzygnost Platelet Factor 4 (PF4) Kit Ref K890633
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Berichrom(R) Antithrombin Iii Ref K883662
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBerichrom Heparin Ref K925200
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBehring Elisa Processor M Ref K841043
Active Regimes: 510(k) Registry: 510(k) ClassClass:IN Protein Standard Py Ref K962410
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus T4 Controls Ref K953097
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEnzygnost Anti-Cmv Igm Test Ref K861363
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOpus Bone Alp Ref K964764
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Rows 51-100 of 146
Showing 51-100 of 146