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Cepheid

904, East Caribbean Drive, Sunnyvale, CA 94089

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 Cepheid
Their homepage, crawled JUL 2026

What they make

Pharmaceutical Preparation Manufacturing325412

The company develops and offers molecular diagnostic tests across multiple disease categories including respiratory infections, infectious diseases, blood virology, women's health, tuberculosis, and oncology. The tests are branded under the Xpert® product line and detect pathogens and genetic markers such as Strep A, influenza, RSV, COVID-19, C. difficile, MRSA, norovirus, hepatitis C, tuberculosis, and various oncology-related mutations.

SUMMARIZED FROM THE COMPANY’S OWN WEBSITE

Products

Made or handled here · 36
Assay, Direct, Nucleic Acid Amplification, Influenza Virus · Assay, Enterovirus Nucleic Acid · Bcr/Abl1 Monitoring Test · C. Difficile Nucleic Acid Amplification Test Assay · Clinical Sample Concentrator · Culture Media, Non-Propagating Transport · Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies · Dna Probe, Nucleic Acid Amplification, Chlamydia · Dna-Reagents, Neisseria · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System · Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System · Instrumentation For Clinical Multiplex Test Systems · Microbial Nucleic Acid Storage And Stabilization Device · Multi-Analyte Controls Unassayed · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections · Reagents, 2019-Novel Coronavirus Nucleic Acid · Reagents, Clostridium Difficile Toxin · Reagents, Monkeypox Virus Nucleic Acid. · Real Time Nucleic Acid Amplification System · Respiratory Specimen Nucleic Acid Sars-Cov-2 Test · Respiratory Virus Panel Nucleic Acid Assay System · Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test · Somatic Gene Mutation Detection System · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen · System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen · System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species · System, Test, Tumor Marker, For Detection Of Bladder Cancer · System, Test, Tumor Marker, Monitoring, Bladder · Test, Factor Ii G20210a Mutations, Genomic Dna Pcr · Test, Factor V Leiden Mutations, Genomic Dna Pcr · Trichomonas Vaginalis Nucleic Acid Amplification Test System · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Where these came from
36 from FDA device registration · Federal registry
FDA device establishment 3004530258, product code NIA; proprietary names: Xpert Flu, Xpres Xpress Flu/RSV, Xpert Flu/RSV XC, Xpert Xpress CoV-2/Flu/RSV plus

Where it is

37.41418, -122.00201 · CENSUS TIGER
COUNTY
METRO AREA
ON GOOGLE MAPS
STREET VIEW

Other plants nearby

FacilityCityIndustryStatusDistance
CepheidSunnyvaleIn-Vitro Diagnostic Substance Manufacturing
325413
 UNVERIFIED0.5 KM
Medi-physics INC Dba Ge HealthcareSunnyvalePharmaceutical Preparation Manufacturing
325412
 UNVERIFIED1.3 KM
Rls (usa) INCSunnyvalePharmaceutical Preparation Manufacturing
325412
 UNVERIFIED1.3 KM
Icon Bioscience INCSunnyvalePharmaceutical Preparation Manufacturing
325412
 UNVERIFIED1.5 KM
5301 Patrick Henry, LLCSanta ClaraPharmaceutical Preparation Manufacturing
325412
 UNVERIFIED1.7 KM

Every listed plant in Santa Clara 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.

EPA cross-references this facility in CARB-TCH, EIS · EPA site type STATIONARY.

SourceEvidenceFirst seenLast seen
FDA DEVICESOPERATINGAUG 2026AUG 2026
COMPANY SITEOPERATINGJUL 2026AUG 2026
SAM GOVOPERATINGNOV 2025NOV 2025
EPA FRSEXISTENCEJUN 2017AUG 2024
FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT
FIELDSOURCESIGNAL
ADDRESS LINE1EPA FRSJUL 2026
ADDRESS LINE1SAM GOVNOV 2025
CAGE CODESAM GOVNOV 2025
CITYEPA FRSJUL 2026
CITYSAM GOVNOV 2025
GEOMCENSUS GEOCODERJUL 2026
GEOMEPA FRSJUL 2026
NAMEEPA FRSJUL 2026
NAMESAM GOVNOV 2025
REGISTRATION EXPIRATIONSAM GOVNOV 2025
STATEEPA FRSJUL 2026
STATESAM GOVNOV 2025
WEBSITESAM GOVNOV 2025

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

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