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
Sigma Diagnostics Infinity Bun Reagent Kit Ref K982236
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIWright-Glemsa Stain Ref K890673
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICalcium (Arsenazo Iii) Reagent Ref K894204
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics CO2 Acid Reagent Ref K963541
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Flow Cytometry Fitc/Pe Compensation Kit Ref K910255
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUric Acid Reagent Ref K853357
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDigitoxin Fpia Calibrator Set Ref K915464
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIThromboplatin-M With Calcium Ref K930212
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAccucolor High Calibrator (A3089) Ref K973274
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAccuclot Control I, Model A4089 Ref K003328
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIActivated Partial Thromboplastin Time Ref K915463
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICk(Optimized) Reagent Ref K854501
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlkaline Phosphatase (Alp) Procedure No. 245 Ref K954840
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAmmonia Controls Low And High #a 5565 & A 6665 Ref K880039
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICholinesterase (Btc) Reagent Ref K863203
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISigma Diagnostics Accuclot Control Iii Ref K981255
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Sigma Diagnostics Bun Reagent Ref K963537
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Angiotensin Converting Enzyme 305-Uv Ref K854245
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITheophylline Fpia Reagent Set Ref K870952
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Kc 4A Micro Coagulation Analyzer Set/System Ref K955735
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIInfinity Cholesterol Reagent (Procedure No. 401) Ref K980667
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITobramycin Fpia Reagent Set And Calibrator Ref K944371
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:II
Sigma Diagnostics Alexin Hs, Models A0969, A1094 Ref K992711
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMicroprotein-Pr Ref K915380
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBun (Rate) Reagent Ref K850923
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Procedure No. 333-Uv Ref K914777
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGlucose (Hk) Reagent (Procedure NO.16) Ref K945908
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P Ref K992800
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIValproic Acid Fpia Reagent Set And Calibrators Ref K943866
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICs-400 Coagulation Analyzer System (A1208) Ref K972260
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAccuclot Drvvt Screen, Catalog No. A6094 Ref K000527
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAccucolor(Tm) Antithrombin Iii Chromogenic Assay Ref K935308
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGlucose(Trinder) Reagent Ref K852130
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIElastic Stain Ref K864074
Active Regimes: 510(k) Registry: 510(k) ClassClass:IGentamicin Fpia Reagent Set And Calibrators Ref K943550
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Proced. 245 Alkaline Phosphatase Ref K841918
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISigma Diagnostics Creatinine Reagent Kit Ref K963534
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIThrombomax-Hs With Calcium, Model T6540 Ref K010158
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIFactor X Deficient Plasma Ref K935054
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIgm Rf Eia Ref K942908
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBile Acids Controls Ref K873342
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAlbumin (Bcp) Ref K863226
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMulti-Analyte Lin-Trol Ref K863751
Active Regimes: 510(k) Registry: 510(k) ClassClass:IVancomycin Fpia Reagent Set Ref K955716
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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