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Diazyme Laboratories, Inc.

Last updated September 17, 2026

About

A leader in innovative diagnostic solutions, is dedicated to advancing healthcare through proprietary enzyme and immunoassay technologies.

From the manufacturer's own website. Source

Information

Country: US
Address: 12889 GREGG CT, POWAY, CA, 92064
Website: www.diazyme.com
LinkedIn: linkedin.com/company/diazyme-laboratories
Facebook: facebook.com/diazymelaboratories
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004445302
DUNS Number: —

Catalogue (228)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Modification To: Direct Enzymatic Hba1c Assay Kit, Model# Dz168a, Dz168a-Cal, Dz168a-Con	K070734	FDA 510(k)	Class II	Active
Homocysteine Microtiter Plate Assay	K032012	FDA 510(k)	Class II	Active
Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set	K133083	FDA 510(k)	Class II	Active
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay	K253358	FDA 510(k)	Class II	Active
Diazyme Homocysteine Enzymatic Assay Kit For Cobas Integra And Homocysteine Calibrator	K061296	FDA 510(k)	Class II	Active
Diazyme Cystatin C Poc Test Kit	K111664	FDA 510(k)	Class II	Active
Diazyme 1, 5-AG Assay	K180209	FDA 510(k)	Class II	Active
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay	K181438	FDA 510(k)	Class II	Active
Diazyme Creatinine Liquid Reagents Assay	K062105	FDA 510(k)	Class II	Active
Diazyme Carbon Dioxide Enzymatic Assay Kit, Model Kz122a	K060619	FDA 510(k)	Class II	Active
Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, And Calibrators, Model(s) Dzxxxa, Dzxxxa-Cal	K071971	FDA 510(k)	Class II	Active
Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model Dz113c-X, Diazyme Liquid Stable Enzymatic Potassium Assay Cal	K091455	FDA 510(k)	Class II	Active
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set	K161646	FDA 510(k)	Class II	Active
Smart Hba1c Assay Kit, Model Dz168b-Poc, Smart Hba1c Assay Control Kit, Model Dz168b-Con, Smart Hbac1c Analyzer	K092911	FDA 510(k)	Class I	Active
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay	K252336	FDA 510(k)	N/A	Active
Diazyme Glycated Serum Protein Poc Test Kit	K133803	FDA 510(k)	Class II	Active
Diazyme Homocysteine Poc Test Kit	K121053	FDA 510(k)	Class II	Active
Diazyme Cystatin C Assay	K093680	FDA 510(k)	Class II	Active
Total Bile Acids Assay, Model Dz042a	K051714	FDA 510(k)	Class II	Active
Diazyme Lipoprotein (a) Calibrator Set, Control Set	K131556	FDA 510(k)	Class II	Active
Diazyme EZ Vitamin D Assay	K172992	FDA 510(k)	Class II	Active
Diazyme DZ-Lite Total beta-hCG Test System	K163418	FDA 510(k)	Class II	Active
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set	K161721	FDA 510(k)	Class II	Active
Diazyme Myoglobin; Assay, Calibrator Set, Control Set	K123785	FDA 510(k)	Class II	Active
Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit	K110188	FDA 510(k)	Class II	Active
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer	K212221	FDA 510(k)	Class II	Active
Diazyme Hs Crp Assay Kit / Calibrator Set / Control Set	K103557	FDA 510(k)	Class II	Active
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set	K162297	FDA 510(k)	Class II	Active

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