Development, manufacture and distribution of diagnostic reagents and automated clinical chemistry analyzers.
Diazyme Laboratories, Inc.
Poway, CA (USA)New on Amplifa
About Diazyme
Diazyme Laboratories Inc., headquartered in Poway, California (USA), specializes in innovative diagnostic solutions and develops, manufactures and distributes diagnostic reagents based on its own enzyme and immunoassay technologies. The product range includes assays for clinically relevant biomarkers such as Lipoprotein(a), Procalcitonin, Calprotectin, free light chains (Kappa/Lambda), Lactoferrin, Cystatin C, Glycated Serum Protein, Creatinine, Total Bile Acids and Vitamin D, complemented by calibrators and control materials. The reagents are formulated as liquid, ready-to-use reagents and can be used on common automated clinical chemistry analyzers. With the DZ-Lite c270, Diazyme offers its own fully automated, compact analyzer capable of up to 270 tests per hour, supporting 1-, 2-, 3- and 4-reagent assays. The products are used by healthcare professionals worldwide. In October 2026, Diazyme acquired the assets of Alfa Wassermann Diagnostic Technologies LLC; in June 2026, the Lipoprotein(a) Molarity Assay received FDA-510(k) clearance.
- Site
- Poway, CA, USA
- Processes
- Research and development of diagnostic reagents, Manufacturing, Distribution, Automated analyzers (DZ-Lite c270)
- Materials
- Fully automated clinical chemistry analyzer, Enzyme and immunoassay technologies, Immunoturbidimetry (latex-enhanced)
- Certificates
- FDA 510(k) (Lipoprotein(a) Molarity Assay)
- Industries
- Clinical Diagnostics, In-Vitro Diagnostics, Laboratory Medicine
- 01
Research & development of diagnostic reagents
- 02
Manufacturing
- 03
Distribution
- 04
Support for automated analyzers
Products & Technologies
Fully automated clinical chemistry analyzer
Compact instrument with up to 270 tests/h, supporting 1-, 2-, 3- and 4-reagent assays.
Enzyme and immunoassay technologies
Proprietary technologies for the quantitative determination of clinical biomarkers in serum and plasma.
Immunoturbidimetry (latex-enhanced)
Particle-enhanced methods, e.g. for Calprotectin, Lactoferrin, Vitamin D and free light chains.
Locations
Poway, CA
USHeadquarters
- DZ-Lite c270 clinical chemistry analyzer (up to 270 tests/h)
Products
Inside the production
Industries
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Fully automated clinical chemistry analyzer | Diazyme DZ-Lite c270 | – | up to 270 tests/h, supports 1-, 2-, 3- and 4-reagent assays | – | – |
Additional services
Quality
The products are designed for the quantitative determination of clinical biomarkers with high precision (e.g. total CV ≤ 1.3% for the Glycated Serum Protein Assay) and defined measurement ranges; the Lipoprotein(a) Molarity Assay is FDA-510(k) cleared.
| Evidence | Poway, CA |
|---|---|
| FDA 510(k) (Lipoprotein(a) Molarity Assay) |
History
- 2026
FDA-510(k) clearance for the Lipoprotein(a) Molarity Assay (June 2026, according to the website).
- 2026
Acquisition of the assets of Alfa Wassermann Diagnostic Technologies LLC (October 2026, according to the website).