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Sclavo, Inc.

United StatesFDA applicant, unverified

Devices
82

What Sclavo, Inc. makes

Sclavo, Inc. manufactures diagnostic reagents and assay kits for clinical laboratory testing, including enzymatic single-reagent tests for cholesterol, acid phosphatase, creatine phosphokinase (CPK), and uric acid. Their portfolio also covers coated tube reagents for phenobarbital and theophylline assays, as well as kinetic and UV-based tests for liver enzymes (AST/GOT, ALT/GPT) and alkaline phosphatase. Additional offerings include chloride testing reagents and a CPK-MB diagnostic kit for cardiac marker analysis.

The company’s diagnostic products are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearances. These devices are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.

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

Catalogue82

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  • C-Reactive Protein Test Kit Ref K822332

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

  • Isoenzyme Test Ck-Mb Ref K850212

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

  • New Enzymatic Single Reagent Free Chol. Ref K822417

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

  • Acp Kinetic Test (Acid Phosphatase Test) Ref K881204

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

  • Diagnostic Kit, Cpk Ref K780311

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

  • Total Iron Binding Capacity Test Ref K884649

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

  • Immpulse Coated Tube Phenobarbital Assay Reagents Ref K865000

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

  • Ast(Got) Uni-Uv, Sgot Ref K780463

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

  • Chloride Test Ref K870630

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

  • Immpulse Coated Tube Theophylline Assay Reagents Ref K864409

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

  • Alkaline Phosphatase Test Ref K771695

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

  • Unifast Ck-Mb Ref K873134

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

  • Fast Uric Acid Ref K870632

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

  • Alt(Gpt) Uni-Uv, Sgpt Ref K780462

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

  • Aso Quantum, Antistreptolysin O Test Ref K801177

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

  • Elisa Rubella Igm Ref K914420

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

  • Inorganic Phosphorus Test Ref K843177

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

  • Immpulse Ferritin Assay Reagent Ref K862014

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

  • Glucose Hexokinase Diag. Kit Ref K831560

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

  • Creatinine Test Ref K843179

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

  • Immpulse Ige Assay Reagents Ref K863327

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

  • Cholinesterase - Acetythiocholine Substrate Ref K880199

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

  • Albumin Screen Test Ref K870516

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

  • Bun Test Uni-Uv Blood Urea Nitrogen Test Ref K780943

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

  • Calcium Reagent Sys Ref K840214

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

  • Fast Cholesterol (Total Cholesterol Test) Ref K862507

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

  • Immpulse Phenobarbital Assay Reagents Ref K862528

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

  • Triglyceride Diagnostic Kit Ref K830288

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

  • Total Bilirubin L.F. Ref K895822

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

  • Diagnostic Kit Free T3 And Free T4 Ref K870268

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

  • Reagents For Tsh Assay Ref K881381

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

  • Total Bilirubin Test Ref K843178

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

  • Elisa Cmv Igm Ref K914789

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

  • Immpulse Digoxin Assay Reagents Ref K874748

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

  • Cholinesterase - Butyrythiocholine Substrate Ref K880049

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

  • Triglyceride's Test (Trigli-Cinet) Ref K854783

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

  • Isocontrol Serum Ck-Mb Ref K850213

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

  • Differential I.M. Screening Test Ref K873297

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

  • Fast Choles-Cinet Ref K812091

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

  • Uni-Fast Creatine Kinase Test (Ck) Ref K872029

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

  • Chol-Hdl Test, High Lipo. Chol Test Ref K792313

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

  • Total Iron Binding Capacity Test Ref K830032

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

  • Amylast-D Test Ref K831561

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

  • Sclavo Chloride Test Ref K843740

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

  • Bnp-Amylase Test Ref K873133

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

  • Iron Test Ref K881202

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

  • Prothrombin Time Test Ref K872537

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

  • Immpulse Phenytoin Assay Reagent Ref K862554

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

  • Reuma Test Ref K873782

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

  • Acid Phosphatase Diag. Kit Ref K781489

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

Rows 1-50 of 82

Showing 1-50 of 82

Frequently asked questions

How many devices does Sclavo, Inc. have in the registry?

The registry currently lists 82 devices for Sclavo, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sclavo, Inc.'s devices?

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

What risk classes do Sclavo, Inc.'s devices fall under?

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

What are the newest devices from Sclavo, Inc. in the registry?

The most recently registered devices listed for Sclavo, Inc. include C-REACTIVE PROTEIN TEST KIT, ISOENZYME TEST CK-MB, NEW ENZYMATIC SINGLE REAGENT FREE CHOL. and ACP KINETIC TEST (ACID PHOSPHATASE TEST).

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