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.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Alt(Optimized) Reagent Ref K854502
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISigma Diagnostics Calicium Reagent Ref K963536
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIInfinity Amylase Reagent (Procedure No. 580/568) Ref K001569
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Procedure No. 735 Ref K897147
Active Regimes: 510(k) Registry: 510(k) ClassClass:IFibrinogen Control Ref K915462
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIFungi Histology Control Slides Ref K881112
Active Regimes: 510(k) Registry: 510(k) ClassClass:IPhenytoin Fpia Calibrators Ref K871423
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPneumocystis Carinii Histology Control Slides Ref K881108
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
No. 615 Determination Of Ceruloplasmin In Serum Ref K860138
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIHeparin Controls, High And Low Ref K910741
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAmax Cs-190 Coagulation Analyzer System Ref K955720
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICO2 Reagent Ref K880268
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Accuclot La Control Ref K020109
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P Ref K992798
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISpirochetes Histology Control Slides Ref K881109
Active Regimes: 510(k) Registry: 510(k) ClassClass:IPhenytoin Fpia Reagent Set And Calibrators Ref K943313
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILegionella Pneumophilla Histology Control Slides Ref K881110
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDigoxin Fpia Reagent Set And Calibrator Set Ref K940569
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Accuclot Control Ii Ref K981254
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Accuclot Control I Ref K981248
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAccuclot Thrombin Time Reagent Model A8713/A4589 Ref K982209
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Infinity Ast Reagent (Procedure No. 51) Ref K980666
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAcid Phosphatase (Acp) Reagent Ref K863851
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Wash Concentrate Ref K963539
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISigms Proced. 228 Uv Lactate Dehydro Ref K841917
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIKc 1A Coagulation Analyzer/Set Ref K955724
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBun (Rate) Reagent Ref K863196
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Glucose Reagent Ref K963535
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Chloride Reagent Ref K864713
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Fibrinogen Determination Kit Ref K913061
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGram Stain Kit Ref K853896
Active Regimes: 510(k) Registry: 510(k) ClassClass:IApolipoprotien B (Apo B) Ref K932603
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Glutamyl-Transferase, Procedure No. 419 Ref K935984
Active Regimes: 510(k) Registry: 510(k) ClassClass:IApolipoprotien A-1 (Apo A-1) Ref K932606
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDigoxin Fpia Controls Ref K872347
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAcid Fast Bacilli Histology Control Slides Ref K881106
Active Regimes: 510(k) Registry: 510(k) ClassClass:IHeparin Adsorbent Ref K912061
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Alkaline Phosphatase (Alp/Amp) Procedure No. 247 Ref K951584
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITissue Gram Stain Ref K864531
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISigma Diagnostics Accucolor Antithrombin Iii Ref K972144
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIntracellular Amyloid Histology Control Slides Ref K881107
Active Regimes: 510(k) Registry: 510(k) ClassClass:IRapid Acid Fast Stain Ref K864033
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISigma's Calcium Procedure No. 587 Ref K871152
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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