Diazyme Laboratories INC

12889 Gregg Ct, Poway, CA 92064

ACTIVELAST SEEN IN FEDERAL DATA AUG 2026 · 3 SOURCES

Operating signal within 12 months from two or more independent sources.

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Their homepage, crawled JUL 2026

What they make

In-Vitro Diagnostic Substance Manufacturing325413

Diazyme Laboratories researches, develops, manufactures, and distributes diagnostic reagents using enzyme and immunoassay technologies for use on automated analyzers. The company produces biomarkers and assays across multiple clinical areas including cancer, cardiovascular, coagulation, diabetes, liver, renal, and other disease markers, as well as therapeutic drug monitoring products. Its products serve healthcare professionals and diagnostic laboratories.

SUMMARIZED FROM THE COMPANY’S OWN WEBSITE

Products

Made or handled here · 39

5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use · Apolipoproteins · Assay, 1,5-Anhydroglucitol (15ag) · Assay, Glycosylated Hemoglobin · Atomic Absorption, Lithium · Calibrator, Multi-Analyte Mixture · Calibrator, Secondary · Calprotectin, Fecal · C-Reactive Protein, Antigen, Antiserum, And Control · Enzymatic, Carbon-Dioxide · Enzymatic Method, Creatinine · Enzyme Controls (Assayed And Unassayed) · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · Fibrinogen Standard · Fibrin Split Products · Hexokinase, Glucose · Kappa, Antigen, Antiserum, Control · Lambda, Antigen, Antiserum, Control · Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl · Ldl & Vldl Precipitation, Hdl · Lipase-Esterase, Enzymatic, Photometric, Lipase · Lipoprotein, Low-Density, Antigen, Antiserum, Control · Myoglobin, Antigen, Antiserum, Control · Nitroprusside, Ketones (Urinary, Non-Quant.) · Plasma, Fibrinogen Control · Radioimmunoassay, Cholyglycine, Bile Acids · Reagent, Coronavirus Serological · Retinol-Binding Protein, Antigen, Antiserum, Control · Single (Specified) Analyte Controls (Assayed And Unassayed) · System, Test, Oxalate · System, Test, Sodium, Enzymatic Method · System, Test, Vitamin D · Test, Cystatin C · Test, Fibrinogen · Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 · Test, System, Potassium, Enzymatic Method · Urinary Homocystine (Nonquantitative) Test System · Oxalate Enzymatic Assay

Where these came from

38 from FDA device registration · Federal registry

FDA device establishment 2032900, product code CED; proprietary names: 5'-Nucleotidase Control Set, 5'-Nucleotidase Calibrator, 5'-Nucleotidase Assay

1 from the company’s own website · Company website

json-ld on https://www.diazyme.com/oxalate-enzymatic-assay/

Where it is

32.93766, -117.04731 · CENSUS TIGER

COUNTY

San Diego County

METRO AREA

San Diego-Chula Vista-Carlsbad, CA

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STREET VIEW

Open street-level view — FEB 2025

Other plants nearby

Facility	City	Industry	Status	Distance
General Atomics - Poway - DPC01	Poway	Medicinal and Botanical Manufacturing 325411	LIKELY ACTIVE	0.0 KM
Mcgowan Enterprises INC Dba Acute Care Pharmaceuticals	Poway	Pharmaceutical Preparation Manufacturing 325412	UNVERIFIED	0.9 KM
Ctk Biotech, INC.	Poway	In-Vitro Diagnostic Substance Manufacturing 325413	ACTIVE	1.6 KM
Gendx Dba Gen Bio	San Diego	In-Vitro Diagnostic Substance Manufacturing 325413	UNVERIFIED	6.8 KM
Innominata Dba Genbio	San Diego	In-Vitro Diagnostic Substance Manufacturing 325413	UNVERIFIED	6.8 KM

Every listed plant in San Diego County

Also at this address

No other federal record shares this street address.

WHERE THIS RECORD COMES FROM — 3 FEDERAL SOURCES, 9 FIELDS

Every fact on this page traces to a public federal filing. The table below names which register holds this facility, whether that register proves the plant operates or only that it exists, and when each of them last saw it.

Source	Evidence	First seen	Last seen
FDA DEVICES	OPERATING	AUG 2026	AUG 2026
COMPANY SITE	OPERATING	JUL 2026	AUG 2026
SAM GOV	OPERATING	MAR 2026	MAR 2026

FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT

FIELD	SOURCE	SIGNAL
ADDRESS LINE1	SAM GOV	MAR 2026
CAGE CODE	SAM GOV	MAR 2026
CITY	SAM GOV	MAR 2026
GEOM	CENSUS GEOCODER	JUL 2026
NAME	SAM GOV	MAR 2026
REGISTRATION EXPIRATION	SAM GOV	MAR 2026
STATE	SAM GOV	MAR 2026
WEBSITE	SAM GOV	MAR 2026
YEAR ESTABLISHED	SITE YEAR	AUG 2026

Status is computed from independent sources; nothing here is self-reported unless marked Claimed.

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