Baxter Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices: 72

What Baxter Diagnostics, Inc. makes

Baxter Diagnostics, Inc. manufactures diagnostic controls, immunoassay cartridges, dried microbiology panels, and reagent kits for laboratory testing. Products include tri-level controls for myoglobin and urine chemistry, EIA assays for herpes simplex virus 2 and rubella IgM, and immunofluorescence (IFA) test kits for parainfluenza and respiratory syncytial virus (RSV) detection. Additional offerings cover Gram-negative bacterial panels and phenytoin reagent strips for clinical monitoring.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. Baxter Diagnostics, Inc. is based in the United States.

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

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Baxter Diagnostics, Inc.

What Baxter Diagnostics, Inc. makes

Catalogue72

Dried Gram-Positive Mic/Combo Panels Ref K943510

Bartels Lyme Disease Igm Eia Ref K922578

Bartels Respiratory Syncytial Virus Enzyme Immuno Ref K912838

Paramax Phenobarbital Reagent And Calibrators Ref K935568

Dade(R) Alpha 2 Antiplasmin(2 2-Ap) Chromo Assay Ref K914818

Stratus Digoxin Flourometric Enzyme Immunoassay Ref K934003

Influenza A Ifa Test For Direct Antigen Detection Ref K884191

Apolipoprotein Test System Ref K921037

Dade(R) Tumor Marker Control Ref K924919

Paramax Alcohol Reagent Ref K934275

Stratus Vitamin B12 Fluorometric Enzyme-Linked Ref K924074

Bartels Epstein-Barr Virus Igg Eia Ref K922332

Dried Gram-Positive Mic/Combo Panels Ref K934458

Dried Gram-Positive Mic/Combo Panels/Cefmetazole Ref K942267

Paramax Total Iron Binding Capacity Pretreatment Ref K923569

Bartels Herpes Simplex Virus 1 Igg Eia Ref K922584

Bartels Epstein-Barr Virus Igm Eia Ref K922331

Dade Hepzyme Ref K925452

Bartels Cytomegalovirus Igg Eia Ref K922582

Stratus(R) Total Thyroxine(T4) Fluor Enzyme Immuno Ref K933426

Dade Recomboplastin S Ref K921326

Antithrombin Iii Chromogenic Assay Ref K936196