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Boehringer Mannheim Corp.

United StatesFDA applicant, unverified

Devices
343

What Boehringer Mannheim Corp. makes

The company manufactures diagnostic reagents, control materials, and assay systems for clinical laboratories, including liquid bilirubin reagents, cholesterol controls, and glycero-based calibration standards. It also produces point-of-care testing devices such as lancets for blood glucose monitoring and coagulation analyzers, alongside immunoassay kits for drug and protein detection (e.g., phenytoin, troponin T). Centrifuges for sample processing and blood urea nitrogen (BUN) test strips are also part of its portfolio.

The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, with many products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the company operates from the United States.

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

Catalogue343

Newest first, rows 251-300 of 343

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  • Cholesterol High Performance-K Ref K832158

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

  • Precinorm Rf, Precipath Rf Ref K973629

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

  • Accu-Chek(R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage H Test Strips Ref K973662

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

  • Single Vial Lactate Ref K780563

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

  • Tina-Quant [A] Crp Ref K871895

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

  • Boehringer Mannheim Cardiac T Tropnin T Ref K955868

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

  • Reagent Set Hdl Cholesterol Ref K780635

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

  • Enzymun Test(R) FT4 (Free Thyroxine) Ref K900883

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

  • Reflotron (R) Amylase Ref K874704

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

  • Elecsys Folate Ref K973674

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

  • Tracker System Ref K860948

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

  • Elecsys Calcheck T4 Ref K963178

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

  • Tracer(Tm) Ii Blood Glucose System Ref K881908

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

  • Elecsys Ca 125 Ii Ref K972162

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

  • Enzymun Test(R) Insulin Ref K901135

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

  • Accu-Check Voicemate Ref K982079

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

  • Boehringer Mannheim Cholesterol Assay Ref K952127

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

  • Enzymun Test R T3 Ref K896900

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

  • Tinaquant Rheumatoid Factor Assay Ref K971379

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

  • Reflotron Hdl Cholesterol Test Tabs Ref K902568

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

  • Bun (Kinetic) Ref K895666

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

  • Chemstrip(R) Micral(Tm) Urine Test Strips Ref K904752

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

  • Coaguchek System Ref K942884

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

  • Accuchek Ii Freedom(Tm) Monitoring System Ref K883817

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

  • Tina-Quant(R) Igm Ref K862762

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

  • Elecsys Tsh Assay Ref K961491

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

  • Cedia Digoxin Calibrators Ref K972433

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

  • Roche Diagnostics Magnesium Reagent, Cat# 1551353 Ref K983416

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

  • Bmc Riaflo System Ref K801481

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

  • Hitachi 914 Analyzer Ref K942364

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

  • Elecsys Cea Assay Ref K964368

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

  • Cyanmethemoglobin Test Ref K820596

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

  • Enzymun Test Tbg Ref K862109

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

  • Reflotron Hemoglobin Test Tabs Ref K934064

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

  • Elecsys Afp Ref K973351

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

  • Tina-Quant(R) Iga Ref K862763

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

  • Cedia Antibiotic Tdm Multi-Cals Ref K963191

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

  • Elecsys Vitamin B12 Assay Ref K973702

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

  • Myoglobin Control Set Ref K973358

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

  • Elecsys Precicontrol Cardiac Ref K962575

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

  • Enzymun Test(R) Tbk Ref K896991

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

  • Unitest Creatine Kinase Ref K782156

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

  • Ck-Mb Ref K771497

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

  • Elecsys Calcheck Lh Ref K964830

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

  • B2-Microglobulin Control Set Serum Ref K982471

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

  • Bicarbonate Ref K874435

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

  • Boehringer Mannheim C.F.A.S. - Hdl/Ldl-C-Plus Ref K974825

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

  • Elecsys Calcheck Hcg Ref K963165

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

  • Precinorm H & Precipath H Ref K850017

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

  • Elecsys Psa, Model 2010 Ref K982949

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

Rows 251-300 of 343

Showing 251-300 of 343