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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

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  • Elecsys 2010 Analyzer Ref K961481

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

  • Advantage Test Strips Ref K951887

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

  • Elecsys Calcheck Cea Ref K970459

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

  • Reflocheck-S Ref K840962

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

  • Diagnostics Hdl Cholesterol Precipitant Ref K821852

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

  • Ria Phase Digoxin Ref K800205

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

  • Tina-Quant Crp Ref K930621

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

  • Tina-Quant Microalbumin Ref K932950

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

  • Tina-Quant [A] Transferrin Ref K871896

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

  • Boehringer Mannheim Diag. Blood Glucose Ref K842393

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

  • Fun-Uv System Pack Test Ref K812290

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

  • Triglycerides Test Ref K760713

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

  • Boehringer Mannheim Diagnostics Adam Ref K843283

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

  • Chemstrip 101 Urine Analyzer Ref K983510

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

  • Elecsys Troponin T Ref K961500

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

  • Test, Ammonia, Bmc Reagentset Ref K770273

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

  • Precipath(R) Im Normal & Abnormal Immuno. Control Ref K902220

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

  • Enzymun Test(R) Lh Ref K900779

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

  • Creatinine Pap Ref K854766

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

  • Elecsys Calcheck Vitamin B12 Ref K974383

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

  • Biotrol-Normal Ref K760597

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

  • Accu-Chek Comfort Curve Test Strip Ref K982002

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

  • Preciset Serum Proteins Calibrator Ref K983469

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

  • Reflotron Uric Acid Ref K861831

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

  • Elecsys Testosterone Assay Ref K964889

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

  • Elecsys T4 Assay Ref K961490

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

  • Total Iron Binding Capacity (Tibc) Ref K880546

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

  • Single Vial Ldh-L Tris Ref K781538

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

  • 8700 Clinical Chem. Analyzer Ref K820888

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

  • Calcium Ref K850281

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

  • Chemstrip Criterion Urine Analyzer Ref K954024

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

  • Glucotrend Basic System Ref K972876

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

  • Elecsys Myoglobin Stat Assay Ref K983176

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

  • Twin Bun/Glucose Ref K861775

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

  • Bio Set Tm Substrate Calibrators Ref K810963

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

  • Accu-Chek Easy Blood Glucose System Ref K923048

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

  • Boehringer Manneheim Diag. Acid Phospha Ref K823087

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

  • Boehringer Mannheim Tina-Quant Ige Test Ref K983185

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

  • Elecsys Calcheck T Update Ref K963181

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

  • Uric Acid/Aldh Ref K802371

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

  • Enzymun Test{r} Cea Ref P860058

    Active Regimes: PMA Registry: PMA Class:II

  • Micur-Mic Systems Ref P820073

    Active Regimes: PMA Registry: PMA Class:II

  • Enzymun-Test{r} Afp Ref P860044

    Active Regimes: PMA Registry: PMA Class:II

Rows 301-343 of 343

Showing 301-343 of 343