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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 151-200 of 343

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  • Reflotron Creatinine Test Tabs Ref K903573

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

  • Precimat(R) C4 Ref K871023

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

  • Elecsys FT3 Ref K963127

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

  • Enxymatic Creatinine Test Ref K812095

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

  • Enzymun-Test Estradiol Ref K913162

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

  • Elecsys Calcheck Troponin T Ref K963143

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

  • Elecsys T-Uptake Assay Ref K961488

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

  • Elecsys Calcheck Fsh Ref K964829

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

  • Ck-Mb/Ld-1 Control System Ref K894207

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

  • Elecsys Lh Assay Ref K964694

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

  • Elecsys Calcheck Troponin T Ref K984372

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

  • -Amylase Eps Ref K882225

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

  • Tina-Quant Ferritin Assay Ref K964282

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

  • Boehringer Mannheim Es 300 Al(Autoloader) Analyzer Ref K932778

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

  • Reflocheck & Glucose Test Strip Sys Ref K834271

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

  • Chemstrip Control Ref K781691

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

  • Pancreatic A-Amylase Pnp Ref K892848

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

  • Tina-Quant Haptoglobin Ref K972639

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

  • Unimeter Calibration Kit Ref K880610

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

  • Elecsys Psa Assay Ref K964351

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

  • Ria Phase Tbg Ref K800204

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

  • Chemstrip Super Ua Urine Analyzer Ref K934042

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

  • Accu-Chek(R) Iii Blood Glucose System Ref K904292

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

  • Single Vial Amylase Pnp Test Ref K823462

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

  • Enzymun-Test Tsh Ref K915195

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

  • Ast (Uv) Test Ref K810390

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

  • Ld-L Tris System Pack Test Ref K820378

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

  • Precimat(R) C3 Ref K871024

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

  • Glucose-Hk System Pack Test Ref K812303

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

  • Reflotron(R) Ast (Got) Ref K870246

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

  • Enzymun Test R Ige Ref K896902

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

  • Linearity Test Kits Ref K912441

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

  • Preciset Cholesterol High Perform Ref K832251

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

  • Es 22 Ref K854243

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

  • Titanium M.E. Muller Type Total Hip Ref K830356

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

  • Reflotron Bilirubin Ref K872818

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

  • Elecsys Ca 125II On The Elecsys 1010 Ref K980240

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

  • Chemcode/Chemtek System Ref K771496

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

  • Boehringer Mannheim Ethyl Alcohol Assay Ref K952839

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

  • Pyridoxal-5-Phosphate Stripes Ref K821805

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

  • Enzymun-Test Progesterone Ref K910683

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

  • Ultrasound Imaging System Ref K780993

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

  • Cedia Theophylline Assay Ref K961462

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

  • Precimat(R) Crp Ref K871055

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

  • Single Vial Colorimetric/Triglycerides Ref K792234

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

  • Chemstrip Urine Analyzer Ref K931602

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

  • Precinorm Hb Ref K852136

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

  • Tina-Quant Prealbumin Ref K972638

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

  • Enzymun-Test Ferritin Ref K860137

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

  • Uric Acid Test, Bmc Autoflo Ref K770272

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

Rows 151-200 of 343

Showing 151-200 of 343