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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 4 of 5

Device	Model / Reference	Registries	Class	Status
Diazyme	DZ168C-K	FDA UDI	N/A	Active
Diazyme	DZ112B-K	FDA UDI	N/A	Active
Diazyme	DZ179A-CON	FDA UDI	N/A	Active
Diazyme	DZ688B-CAL	FDA UDI	N/A	Active
Diazyme	DZ132A-CON	FDA UDI	N/A	Active
Diazyme	DZ865A-KY1	FDA UDI	N/A	Active
Diazyme	DZ131B-K	FDA UDI	N/A	Active
Diazyme	DZ568B-BY2	FDA UDI	N/A	Active
Diazyme	DZ568B-K	FDA UDI	N/A	Active
Diazyme	DZ568A-CON	FDA UDI	N/A	Active
Diazyme	DZ169A-KY1	FDA UDI	N/A	Active
Diazyme	DZ113C-CAL	FDA UDI	N/A	Active
Diazyme	DZ169A-CON	FDA UDI	N/A	Active
Diazyme	DZ128A-KB1	FDA UDI	N/A	Active
Diazyme	DZ129A-KD1	FDA UDI	N/A	Active
Diazyme	DZ138A-CON	FDA UDI	N/A	Active
Diazyme	DZ072B-CON	FDA UDI	N/A	Active
Diazyme	DZ888A-K	FDA UDI	N/A	Active
Diazyme	DZ112B-LIN	FDA UDI	N/A	Active
Diazyme	DZ135B-SMA	FDA UDI	N/A	Active
Diazyme	DZ122A-KY2	FDA UDI	N/A	Active
Diazyme	DZ136A-K	FDA UDI	N/A	Active
Diazyme	DZ170A-KA1	FDA UDI	N/A	Active
Diazyme	DZ888A-K01	FDA UDI	N/A	Active
Diazyme	DZ179A-K	FDA UDI	N/A	Active
Diazyme	DZ131A-CAL	FDA UDI	N/A	Active
Diazyme	DZ116B-CON	FDA UDI	N/A	Active
Diazyme Hdl-Cholesterol Reagent, Calibrator, Controls	K072395	FDA 510(k)	Class I	Active
Diazyme PLAC® Test for Lp-PLA2 Activity	K203136	FDA 510(k)	Class II	Active
Diazyme Liquid Stable Enzymatic Sodium Assay, Model Dz114b	K082763	FDA 510(k)	Class II	Active
Diazyme Homocysteine Assay Buffer Based Calibrators	K102638	FDA 510(k)	Class II	Active
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set	K143470	FDA 510(k)	Class II	Active
Diazyme Potassium Enzymatic Assay Kit	K042191	FDA 510(k)	Class II	Active
Diazyme Liquid Stable Enzymatic Lithium Assay, Model Dz116b	K082001	FDA 510(k)	Class II	Active
Diazyme Sodium Enzymatic Assay	K042189	FDA 510(k)	Class II	Active
Diazyme Hscrp Poc Test Kit	K121558	FDA 510(k)	Class II	Active
Diazyme 25-Hydroxy Vitamin D Assay Kit Model Dz688a, Diazyme 25-Hydroxy Vitamin D Assay Calibrator Set Model Dz688a-Cal,	K102432	FDA 510(k)	Class II	Active
Diazyme 25-Hydroxy Vitamin D Eia Kit Diazyme 25-Hydroxy Vitamin D Eia Control Set Dia	K122420	FDA 510(k)	Class II	Active
Diazyme Cystatin C: Assay Kit (dz133a-K), Calibrator (dz133a-Cal), Controls (dz133a-Con)	K072270	FDA 510(k)	Class II	Active
Diazyme 25-Oh Vitamin D Assay; Diazyme 25-Oh Vitamin D Control Set	K133410	FDA 510(k)	Class II	Active
Diazyme Lipoprotein (a) Assay	K180074	FDA 510(k)	Class II	Active
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set	K160762	FDA 510(k)	Class II	Active
Modification To: Diazyme Potassium Enzymatic Assay, Model Dz113a	K053566	FDA 510(k)	Class II	Active
Diazyme Glycated Serum Protein Enzymatic Assay Kit	K042193	FDA 510(k)	Class II	Active
Diazyme Colorimetric Lithium Assay	K243462	FDA 510(k)	Class II	Active
Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx	K073488	FDA 510(k)	Class I	Active
Diazyme D-Dimer Assay Kit, Calibrator Setand Control Set	K112120	FDA 510(k)	Class II	Active
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator	K153394	FDA 510(k)	Class II	Active
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	K220001	FDA 510(k)	Class II	Active
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	K211648	FDA 510(k)	Class II	Active

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