Sclavo, Inc.

United StatesFDA 510(k) 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.

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Sclavo, Inc.

What Sclavo, Inc. makes

Catalogue82

Immpulse Free Estriol Assay Reagents Ref K860900

Analyzer, 751 Kinetic/Endpoint Ref K770306

Slavo Cholesterol Stand. Diagnostic Kit Ref K800770

Unifast Activated Partial Thromboplastin Time Test Ref K882325

Isoenzyme Test Ld-1 Ref K850210

Calcium Test Ref K870629

Isocontrol Serum Ld- Ref K850211

Cholesterol Test Ref K770265

Alpha-Amylase Test Ref K860665

Uni-Fast Lactate Dehydrogenase (Ldh-L) Ref K872030

Sodium/Potassium Reagent Sys Ref K840216

Serum Iron Diagnostic Test Kits Ref K830104

Modified Crp Latex Test Ref K880016

Atypical Cholinesterase Ref K873496

Ldh-L Test Ref K770267

Creatinine 340 (Enzymatic) Ref K895847

Unifast Gamma-Gt Ref K873135

Unifast Calcium Test Ref K864661

Fast Glucose Ref K870631

Normal And Abnormal Control Sera Ref K895943

Salicylate Test Ref K843180

Uni-Fast Analyzer System Ref K840129

Blood Urea Nitrogen Reagent Sys Ref K840213

Immpulse T4 Assay Reagents Ref K875081

Immpulse Coated Tube Phenytoin Assay Reagents Ref K865102

Bun-Color 2, Blood Urea Nitrogen Test Ref K800902

Saitron 430 Random Access Chemistry Analyzer Ref K884035

Phosphorus Reagent System Ref K840215

Y-Gt Test, Y-Glutamyl Transferase Test Ref K800769

Potassium Test Ref K863486

Immpulse T, Assay Reagents Ref K881214

Elisa Toxo Igm Ref K914852