Diagnostic Systems Laboratories, Inc.

United StatesFDA applicant, unverified

Devices: 94

What Diagnostic Systems Laboratories, Inc. makes

Diagnostic Systems Laboratories, Inc. manufactures in vitro diagnostic (IVD) immunoassay kits for hormone and protein analysis, including radioimmunoassays (RIAs) and enzyme-linked immunosorbent assays (ELISAs). Products cover thyroid hormones (e.g., T3), parathyroid hormone (PTH), insulin, sex hormones (e.g., DHEA, androstenedione), and biomarkers like alpha-fetoprotein (AFP) and beta-2 microglobulin. Some assays are designed for intact hormone detection, while others measure crosslinked proteins or non-extracted biomarkers.

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with many products authorised via the 510(k) pathway. These assays are intended for laboratory use in diagnosing or monitoring endocrine, metabolic, and oncological conditions. The manufacturer is based in the United States.

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

Catalogue94

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What Diagnostic Systems Laboratories, Inc. makes

Catalogue94

Dsl 9100 Igf-Ii Irma Ref K962758

Dsl Ultra-Sensitive Calcitonin Ria (Dsl 5200) Ref K914429

Active Igf-I Elisa Ref K951752

Dsl C-Peptide Ria (Dsl #7000) Ref K896420

C-Terminal Pth Ria Kit Ref K853784

Dsl 1600 Ref K822898

Active Inhibin-A Elisa, Model Dsl-10-28100 Ref K002128

Dsl Dhea (Dsl 8900) Ref K921534

Dsl Beta 2 Microglobulin (Dsl 6100) Ref K912173

Active Ultrasensitive Unconjugated Estriol Eia Ref K962875

Dsl Pap Ria -DSL#3100 Ref K844679

Axsym Intact Pth, Model 2G06 Ref K020945

Calcitonin Ria Kit Ref K854240

Active Androstenedione Eia Ref K963002

Dsl Dhea-S-7 Ref K962895

Free Testosterone Enzyme Immunoassay, Model Dsl-10-4900 Ref K001086

Dsl 1020 Ref K821068

Active Ultra-Sensitive Unconjugated Estriol Ref K955356

Dsl Active Testosterone Ria (Dsl #4000) Ref K854671

Dsl Active Prolactin Elisa Model 10-4500 Ref K960561

Active Cortisol Dsl 2000-Sp Ref K850141

Dsl Active Igfbp-3 Irma (Dsl 6600) Ref K950228

Active Dhea-Sulfate DSL3500 Ref K851239

Dsl Active T4 Eia Ref K971269

Dsl Active Fsh Irma Ref K962118

Dsl Active Prolactin Irma Ref K960060

Dsl Sex Hormone Binding Globulin (Shbg) (Dsl 6300) Ref K904100

Calcitonin Ria Test Kit, Dls 1200 Ref K821675

Dsl Somatomedin-C (Dsl #5600) Ref K875229

Active Testosterone Eia (Dsl-10-4000) Ref K971823

Dsl Active Aldosterone Ria (Dsl 8600) Ref K943397

Dsl 1700 Ref K822897

Dsl Active 17A-Oh Progesterone Ria (Dsl 5000) Ref K943148

Modified Dsl-2300 Acth Ria Ref K900147

Dsl Active BETA2-Microglobulin (Dsl 6500) Ref K915508

Acth Ria System-Dsi 2300 Ref K830893

Dsl-4800 Active Tm Tsh Eia System Ref K864134

Acth Standard Matrix Ref K842099

Dsl Ferritin Irma Ref K841925

Dsl Active Androstenedione Ria (Dsl #3800) Ref K854650

Dsl Active T3 Eia Ref K971270

Active Free Testosterone Ria Ref K952281

Modified Calcitonin Ria Kit Dsl #1200 Ref K874087

Dsl Active Aldosterone (Dsl 8600) Ref K921205