Cepheid

FDA Device Registration & Listing · Lodi, CA, US · Registration 3016838963

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016838963
FEI Number
3016838963
Entity Name
Cepheid
City/State/Country
Lodi, CA, US
Establishment Address
121 N Guild Ave, 1175 S Guild Avenue, Lodi, CA 95240, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CEPHEID (Owner Number: 9062742)
Owner / Operator Contact Address
904 CARIBBEAN DRIVE, --, Sunnyvale, CA 94089, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K173398
PMA Number
N/A

All Registered Proprietary Names

Xpert FII & FV Xpert TV Xpert Urine Specimen Collection kit Xpert® Hemorrhagic Fever Xpert GBS LB XC Xpert NPM1 Mutation Xpert Xpress Strep A Xpert Xpress MVP Xpert Swab Specimen Collection Kit XPERT GBS Xpert Xpress Flu/RSV Xpert HCV Xpert SA Nasal Complete Xpert Xpress CoV-2/Flu/RSV plus Xpert Xpress CoV-2 plus Xpert® Xpress CoV-2 plus Xpert Xpress CoV-2/Flu/RSV plus Xpert Check Xpert Xpress Flu/RSV Xpert MRSA/SA Blood Culture Xpert Bladder Cancer Monitor Xpert Xpress GBS Xpert Swab Specimen Collection Kit Xpert Xpress MVP Xpert Carba-R Xpert MRSA/SA Blood Culture Xpert FII & FV Xpert Mpox Xpert vanA Xpert GBS LB Xpert MRSA/SA SSTI Xpert Check Xpert Carba-R Xpert Flu/RSV XC Xpert Flu Xpres Xpress Flu/RSV Xpert Xpress CoV-2/Flu/RSV plus Xpert Xpress Flu Xpert C.difficile Xpert C.difficile / Epi XPERT MRSA Xpert BCR-ABL Ultra Xpert Xpress CoV-2/Flu/RSV plus Xpert MTB/RIF Xpert Xpress CoV-2/Flu/RSV plus Xpert Carba-R Xpert C.difficile Xpert Xpress Strep A

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr Hematology Class 2 864.7280 2025-05-21
NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr Hematology Class 2 864.7280 2025-05-21
OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System Immunology Class 2 866.3860 2024-12-11
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2024-12-11
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2024-12-11
QVR Multiplex Nucleic Acid Detection System For Biothreat Agents Immunology Class 2 866.4000 2026-05-27
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2022-06-08
QDC Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies Pathology Class 2 866.6100 2024-12-11
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Microbiology Class 2 866.2680 2017-09-26
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2022-04-08
PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Microbiology Class 2 866.3975 2022-04-08
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2004-04-13
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2017-02-15
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2017-02-15
SBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test Microbiology Class 2 866.3171 2024-07-02
NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Microbiology Class 2 866.1640 2024-12-11
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2024-12-11
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-11-16
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Microbiology Class 2 866.3981 2023-11-10
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2025-05-21
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2024-12-18
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2020-06-09
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2020-06-09
NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Microbiology Class 2 866.1640 2013-11-13
MMW System, Test, Tumor Marker, Monitoring, Bladder Immunology Class 2 866.6010 2020-12-04
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2025-02-11
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Microbiology Class 2 866.3981 2025-02-20
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2023-11-02
PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Microbiology Class 2 866.3975 2022-08-17
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2022-08-17
POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Microbiology Class 2 866.1640 2020-12-04
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2024-12-11
NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Microbiology Class 2 866.1640 2024-12-11
NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr Hematology Class 2 864.7280 2023-04-05
NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr Hematology Class 2 864.7280 2023-04-05
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2023-04-05
QTP Reagents, Monkeypox Virus Nucleic Acid. Unknown Class N N/A 2023-02-13
NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species Microbiology Class 2 866.1640 2010-12-14
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2010-12-14
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2012-12-07
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2012-12-07
NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Microbiology Class 2 866.1640 2008-10-17
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2012-12-11
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2024-12-11
POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Microbiology Class 2 866.1640 2024-12-11
NIA Assay, Direct, Nucleic Acid Amplification, Influenza Virus Microbiology Class 1 866.3330 2020-03-04
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2017-02-15
OMN C. Difficile Nucleic Acid Amplification Test Assay Microbiology Class 1 866.2660 2011-12-01
NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Microbiology Class 2 866.1640 2006-04-25
OYX Bcr/Abl1 Monitoring Test Medical Genetics Class 2 866.6060 2019-10-10
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2019-10-10
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2023-08-18
PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen Microbiology Class 2 866.3373 2024-12-11
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2025-05-21
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2018-01-16
PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony Microbiology Class 2 866.1640 2018-01-16
POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Microbiology Class 2 866.1640 2018-01-16
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2009-11-20
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2022-09-09
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Microbiology Class 2 866.2680 2022-09-09

Official Correspondent

Somesh Lalithraj

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CEPHEID
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004530258 CEPHEID Sunnyvale, CA, US
3009613136 CEPHEID AB SOLNA Stockholm, SE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K914894 Microtest VIRAPURE, CHLAMYPURE AND MYCOPURE 1991-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2018 Cepheid N/A
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.
Z-0027-2018 Hologic, Inc 2
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0042-2025 Luminex Molecular Diagnostics Inc 2
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0004-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016838963. Last updated year: 2026. Please use registration number 3016838963 when referencing this establishment in official correspondence.
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