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Ark Diagnostics, INC.

48089 Fremont Blvd, Fremont, CA 94538

ACTIVELAST SEEN IN FEDERAL DATA AUG 2026 · 4 SOURCES

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

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Homepage of Ark Diagnostics, INC.
Their homepage, crawled JUL 2026

What they make

In-Vitro Diagnostic Substance Manufacturing325413

The company designs, develops, and manufactures in vitro diagnostic immunoassays for therapeutic drug monitoring and urine drug testing. The assays use homogeneous enzyme immunoassay technology and are supplied as liquid, stable, ready-to-use products compatible with clinical chemistry systems. The company serves clinical laboratories monitoring epilepsy medications, cancer therapeutics, antibiotics, and antifungals, and holds CE Mark and FDA clearance for products in these categories.

SUMMARIZED FROM THE COMPANY’S OWN WEBSITE

Products

Made or handled here · 19
Calibrators, Drug Specific · Drug Specific Control Materials · Enzyme Immunoassay, Amphetamine · Enzyme Immunoassay, Cannabinoids · Enzyme Immunoassay, Gentamicin · Enzyme Immunoassay, Methadone · Enzyme Immunoassay, Methotrexate · Enzyme Immunoassay, Opiates · Enzyme Immunoassay, Oxcarbazepine Metabolite · Enzyme Immunoassay, Phencyclidine · Gabapentin Assay · Immunoassay, Anti-Seizure Drug · Lamotrigine Assay · Levetiracetam Assay · Radioimmunoassay, Vancomycin · Test, Benzodiazepine, Employment And Insurance Testing, Exempt · Test, Opiates, Employment And Insurance Testing, Exempt · Test Reagents For Ethyl Alcohol · Voriconazole Test System
Where these came from
19 from FDA device registration · Federal registry
FDA device establishment 3005755244, product code DLJ; proprietary names: ARK Zonisamide Calibrator, ARK Zonisamide Assay, ARK Zonisamide Control

Where it is

37.47021, -121.93784 · CENSUS TIGER
COUNTY
METRO AREA
ON GOOGLE MAPS
STREET VIEW

Other plants nearby

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CAPS FremontFremontPharmaceutical Preparation Manufacturing
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Arbor Vita CORPFremontIn-Vitro Diagnostic Substance Manufacturing
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Clip HealthFremontIn-Vitro Diagnostic Substance Manufacturing
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Citragen Pharmaceuticals INCFremontPharmaceutical Preparation Manufacturing
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Every listed plant in Alameda County

Also at this address

No other federal record shares this street address.

WHERE THIS RECORD COMES FROM — 4 FEDERAL SOURCES, 8 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.

SourceEvidenceFirst seenLast seen
COMPANY SITEOPERATINGJUL 2026AUG 2026
FDA DEVICESOPERATINGAUG 2026AUG 2026
SAM GOVOPERATINGFEB 2026FEB 2026
EPA FRSEXISTENCEAUG 2019AUG 2019
FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT
FIELDSOURCESIGNAL
ADDRESS LINE1EPA FRSJUL 2026
ADDRESS LINE1SAM GOVFEB 2026
CAGE CODESAM GOVFEB 2026
CITYEPA FRSJUL 2026
CITYSAM GOVFEB 2026
GEOMCENSUS GEOCODERJUL 2026
GEOMEPA FRSJUL 2026
NAMEEPA FRSJUL 2026
NAMESAM GOVFEB 2026
REGISTRATION EXPIRATIONSAM GOVFEB 2026
STATEEPA FRSJUL 2026
STATESAM GOVFEB 2026
WEBSITESAM GOVFEB 2026

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

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