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Icl Scientific

Country not established

Devices
48

What Icl Scientific makes

Icl Scientific manufactures diagnostic reagents and test systems for immunology and hematology, including enzyme-linked assays, immunoquantitation methods, and serum controls. Products cover thyroid function tests (e.g., T4 uptake, TSH), coagulation factors (e.g., antithrombin III, C1 inhibitor), and autoimmune markers (e.g., anti-DNA antibodies, C-reactive protein). The portfolio also includes reference standards like control sera and specific antisera for laboratory use.

The company’s products are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I (general controls) and Class II (special controls). These reagents and test systems are intended for in vitro diagnostic use in clinical laboratories. The manufacturer is based in the United States.

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

Catalogue48

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  • Enzyme-Test Tbc T4 Uptake Ref K820879

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

  • Antithrombin Iii Serum, Anti-Human Ref K781026

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

  • Ceruoplasmin Serum Anti-Human Ref K781024

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

  • Enzymune System I Ref K822465

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

  • Enzymune-Test Tsh Ref K832823

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

  • Kova Trol Iii Ref K780482

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

  • Aip System-Method For Igm Ref K803251

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

  • Electro-Immuno-Quantitation (Eiq) Ref K792472

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

  • Anti-Human C1 Inhibitor Serum (Goat) Ref K781017

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

  • Immunology Control Serum Ref K810056

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

  • Sle Anti-N-Dna Latex Test Ref K810226

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

  • Lambda Serum (Free) Anti-Human Ref K781025

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

  • Enzyme-Test Digoxin Ref K823199

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

  • Systemic Lupus Erythermatosus Anti-N-Dna Ref K821097

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

  • Event-Test Slide Ref K831383

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

  • Aim System (For Iga) Ref K811125

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

  • Kova Trol I Human Urine (Dried) Ref K810917

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

  • Histimune Enzyme-Ana Test Ref K822346

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

  • Anti-Human Ldl Serum Ref K781015

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

  • Therapeutic Drug Control Ref K833761

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

  • Rid System-Quad Multitest Igg, Iga, Etc. Ref K800897

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

  • Kova Strip 6 Ref K811219

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

  • Kova Trol I, Ii, Iii Human Urine-Dried Ref K843565

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

  • Kappa Serum (Free) Anti-Human Ref K781027

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

  • Enzymune-Test Digoxin Ref K821000

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

  • Enzym-Linked T3 Ref K820763

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

  • Automated Immunoprecipitin Method/Iga Ref K803274

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

  • Enzymune-Test Insulin Ref K821374

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

  • Therapeutic Drug Control Ref K811756

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

  • Proactivator C3, C4 And C3 Ref K790059

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

  • Anti-Human Ciq Serum Ref K781022

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

  • Therapeutic Drug Control Ref K822777

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

  • Automated Immunoprecipitin Method/Icg Ref K803272

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

  • Anti-Human Lambda Serum Ref K781220

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

  • Antiserum To Human Immunoglobulins Ref K791824

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

  • Rid System-Human C-Reactive Protein Ref K780325

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

  • Enzymune-Test T4 Ref K820750

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

  • Hycor Sentry Drugs Of Abuse Urine Control Ref K883942

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

  • Antistreptolysin (Aso) Latex Slide Test Ref K790831

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

  • Alpha-1-Acid Glycoprotein Serum, Anti-Hu Ref K781023

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

  • C3PA (Gbg) Properdin Factor B Ref K781016

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

  • Test, Slide For C-Reative Protein Ref K760354

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

  • Aim System (For Igg) Ref K811126

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

  • Rid Systems - Alph-1-Acid Glycoprotein Ref K792314

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

  • Aim System (For Igm) Ref K811124

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

  • Rid System-(Acp) Test Ref K781408

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

  • Kappa Serum (Free & Bound) Anti-Human Ref K781028

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

  • Systemic Lupus Ref K790257

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

Rows 1-48 of 48

Frequently asked questions

How many devices does Icl Scientific have in the registry?

The registry currently lists 48 devices for Icl Scientific. Devices recorded under merged duplicate company entries are counted once.

Which registries list Icl Scientific's devices?

Among its 48 most recently registered devices, Icl Scientific has devices listed in FDA 510(k) (48 devices).

What risk classes do Icl Scientific's devices fall under?

Among its 48 most recently registered devices, the classes recorded for Icl Scientific's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Icl Scientific in the registry?

The most recently registered devices listed for Icl Scientific include ENZYME-TEST TBC T4 UPTAKE, ANTITHROMBIN III SERUM, ANTI-HUMAN, CERUOPLASMIN SERUM ANTI-HUMAN and ENZYMUNE SYSTEM I.

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