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Gilford Diagnostics

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Devices
50

What Gilford Diagnostics makes

Gilford Diagnostics manufactures chemical reagents and standards for clinical laboratory testing, including diluents, albumin reagents, blood sugar assays, uric acid standards, and reagents for measuring calcium, ALT, cholinesterase, lithium, creatinine, HDL, BUN, and chloride levels.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue50

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  • Cesium Diluent 7.5M Ref K811886

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Albumin Reagent Ref K781773

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Blood Sugar Ref K781783

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Uric Acid Standard Ref K792046

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gilchem Calcium Reagent Ref K812110

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Alt Reagent Ref K800038

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Cholinesterase Reagent Ref K791725

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Lithium Standard (1mm/L) Ref K800042

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gilchem Creatinine Reagent Ref K812109

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Hdl Reagent Ref K800996

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Bun Reagent Ref K800341

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Chloride Reagent Ref K792605

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Uric Acid Reagent Ref K791754

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Triglyceride Reagent (Color) Ref K801012

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Direct Bilirubin Reagent Ref K831844

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Cholesterol Reagent Ref K810405

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Glucose (Gdh) Reagent Ref K791213

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ldh (L-P) Reagent Ref K800120

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Lithium Diluent (1500 Mm/E) Ref K800039

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ahbd Ref K822739

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Asi Reagent Ref K800065

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gilchem Alp Reagent Ref K812912

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Triglyceride Reagent (Uv) Ref K823709

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Cholesterol Calibrators Ref K812861

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Inorganic Phosphorus Reagent Ref K791708

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Gilchem Total Bilirubin Reagent Ref K831843

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • CO2/Ci Standards Ref K822289

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sodium/Potassium (100/100 Meq/E) Ref K800040

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Total Protein Ref K781774

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Cesium Diluent (1.5 Mm/L) Ref K800043

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Bilirubin Calibrators Ref K822334

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Glucose (Trinder) Reagent Ref K801600

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Creatine Kinase Reagent Ref K803301

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ld-P Reagent (Ldh P-L Reagent) Ref K790771

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Glucose (Hk) Reagent Ref K790786

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Creatinine Reagent Ref K811659

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Triglyceride Calibrators Ref K813478

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Albumin/Total Protein Standards Ref K802632

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Creatinine Standards Ref K802631

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ammonia Reagent Ref K821719

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Bun Ref K781782

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gilchem Acid Phosphatase Reagent Ref K820975

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Calcium/Phosphorus/Magnesium Standard Ref K791874

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Bilirubin Calibrators & Control Ref K832094

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gilchem Y-Gt Reagent Ref K822149

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Bun/Glucose Standards Ref K802633

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sodium/Potassium 140/5 Meq/L) Ref K800041

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Ast Ref K781784

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Gil Chem Magnesium Reagent Ref K820976

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ldh Ref K781775

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

Rows 1-50 of 50

Frequently asked questions

How many devices does Gilford Diagnostics have in the registry?

The registry currently lists 50 devices for Gilford Diagnostics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gilford Diagnostics's devices?

Among its 50 most recently registered devices, Gilford Diagnostics has devices listed in FDA 510(k) (50 devices).

What risk classes do Gilford Diagnostics's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Gilford Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gilford Diagnostics in the registry?

The most recently registered devices listed for Gilford Diagnostics include CESIUM DILUENT 7.5M, ALBUMIN REAGENT, BLOOD SUGAR and URIC ACID STANDARD.

Generated automatically from registry data and not verified by a human reviewer.