Sigma Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices: 164

What Sigma Diagnostics, Inc. makes

Sigma Diagnostics, Inc. manufactures diagnostic reagent sets, calibrators, and controls for laboratory testing, including total thyroxine (T4), glucose, albumin, bile acids, liver enzymes (e.g., ALT, ALP), bilirubin, ethanol, valproic acid, reticulocyte stains, and iron/UIBC assays. Their products are designed for fluorescence polarization immunoassays (FPIA) and spectrophotometric procedures, supporting clinical chemistry and toxicology applications.

The company’s portfolio includes Class I and Class II devices under FDA regulation, with many products listed via the 510(k) pathway. These reagents and controls are intended for in vitro diagnostic use and are distributed globally, with the manufacturer headquartered in the United States.

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

Catalogue164

Newest first, rows 151-164 of 164

Search and filter all 164 devices

Creatinine Reagent Ref K873365

Active Regimes: 510(k) Registry: 510(k) Class:II
Sigma Diagnostics Sigma-Cal, Model S2936 Ref K010652

Active Regimes: 510(k) Registry: 510(k) Class:II
Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 Ref K013545

Active Regimes: 510(k) Registry: 510(k) Class:II
Theophylline Fpia Calibrators Ref K871394

Active Regimes: 510(k) Registry: 510(k) Class:II
Triglyceride Reagent Ref K844032

Active Regimes: 510(k) Registry: 510(k) Class:I
Sigma Diagnostics Infinity Uric Acid Reagent Kit Ref K982251

Active Regimes: 510(k) Registry: 510(k) Class:I
New Fuchsin Solution Ref K871545

Active Regimes: 510(k) Registry: 510(k) Class:I
Infinity Hba Kit, Models 537-A, 537-B Ref K012410

Active Regimes: 510(k) Registry: 510(k) Class:II
Sigma Procedure No. 465 For Deter. Of Fructosamine Ref K884184

Active Regimes: 510(k) Registry: 510(k) Class:II
Triglyceride (Gpo-Trinder) Reagent Ref K870012

Active Regimes: 510(k) Registry: 510(k) Class:I
Phenytoin Fpia Reagent Set Ref K870953

Active Regimes: 510(k) Registry: 510(k) Class:II
Primidone Fpia Reagent Set And Calibrators Ref K950028

Active Regimes: 510(k) Registry: 510(k) Class:II
Sigma Diagnostics Auto D-Dimer, Model CRS126-A Ref K003267

Active Regimes: 510(k) Registry: 510(k) Class:II
Sigma Diagnostics CO2ALKALINE Buffer Ref K963538

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

Rows 151-164 of 164

Showing 151-164 of 164

What Sigma Diagnostics, Inc. makes

Catalogue164

Creatinine Reagent Ref K873365

Sigma Diagnostics Sigma-Cal, Model S2936 Ref K010652

Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 Ref K013545

Theophylline Fpia Calibrators Ref K871394

Triglyceride Reagent Ref K844032

Sigma Diagnostics Infinity Uric Acid Reagent Kit Ref K982251

New Fuchsin Solution Ref K871545

Infinity Hba Kit, Models 537-A, 537-B Ref K012410

Sigma Procedure No. 465 For Deter. Of Fructosamine Ref K884184

Triglyceride (Gpo-Trinder) Reagent Ref K870012

Phenytoin Fpia Reagent Set Ref K870953

Primidone Fpia Reagent Set And Calibrators Ref K950028

Sigma Diagnostics Auto D-Dimer, Model CRS126-A Ref K003267

Sigma Diagnostics CO2ALKALINE Buffer Ref K963538