Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004530258

FEI Number

3004530258

Entity Name

CEPHEID

City/State/Country

Sunnyvale, CA, US

Establishment Address

904 CARIBBEAN DRIVE, Sunnyvale, CA 94089, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CEPHEID (Owner Number: 9062742)

Owner / Operator Contact Address

904 CARIBBEAN DRIVE, --, Sunnyvale, CA 94089, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240016

PMA Number

N/A

All Registered Proprietary Names

Xpert Carba-R GeneXpert Edge System (For Export Only) GeneXpert Edge X SMARTCYCLER DX SYSTEM AND SOFTWARE Xpert FII & FV Xpert MTB/RIF Xpert MTB/XDR Xpert MTB/RIF Ultra Xpert FFPE Lysis Kit Xpert GI Panel Xpert MRSA/SA Blood Culture Xpert FII & FV Xpert CT/NG Xpert MRSA/SA BC Xpert SA Nasal Complete Xpert MRSA NxG Xpert MRSA/SA Blood Culture Xpert MRSA /SA SSTI Xpert HemosIL FII & FV Xpert FII & FV Xpert CT XPERT GBS Xpert C.difficile Xpert C.difficile / Epi Xpert Nasopharyngeal Sample Collection kit Xpert Xpress Flu Xpert Nasal Sample Collection Kit Xpert Check XPERT EV Xpert Xpress Strep A Xpert BCR-ABL Ultra Xpert BCR-ABL Ultra p190 Xpert SA Nasal Complete Xpert Carba-R Xpert Xpress Flu/RSV Xpert MRSA/SA Blood Culture Xpert Xpress Flu/RSV GeneXpert DX systems GeneXpert Infinity-48s system GeneXpert Infinity-80 System GeneXpert Xpress System GeneXpert system with Touchscreen GeneXpert Infinity Systems Xpert Check Xpert Nasal Sample Collection Kit Xpert Nasopharyngeal Sample Collection Kit XPERT Xpress Flu Xpert vanA Xpert Breast Cancer STRAT4 Xpert MTB/RIF Xpert GBS LB XC Xpert NPM1 Mutation Xpert Swab Specimen Collection Kit Xpert Xpress MVP Xpert SA Nasal Complete Xpert TV Xpert Urine Specimen Collection kit Xpert FII & FV Xpert Xpress CoV-2/Flu/RSV plus Xpert GBS LB Xpert Xpress Flu Xpert vanA Xpert Xpress MVP Xpert Bladder Cancer Monitor Xpert MRSA/SA SSTI Xpert MTB/RIF Xpert BCR-ABL Ultra Xpert Xpress Step A Xpert Flu/RSV XC Xpert Flu Xpres Xpress Flu/RSV Xpert Xpress CoV-2/Flu/RSV plus Xpert® Xpress CoV-2 plus Xpert C.difficile Xpert TV Xpert MRSA NxG Xpert Mpox Xpert Xpress SARS-CoV-2 Xpert Xpress CoV-2 plus Xpert Xpress SARS-CoV-2/Flu/RSV Xpert Bladder Cancer Detection Xpert HCV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-12-14
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2004-04-13
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
PEU	System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen	Microbiology	Class 2	866.3373	2020-03-04
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2024-12-12
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2026-01-28
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2013-11-13
NPR	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr	Hematology	Class 2	864.7280	2024-12-11
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2020-03-04
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2015-06-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2009-11-20
NPQ	Test, Factor V Leiden Mutations, Genomic Dna Pcr	Hematology	Class 2	864.7280	2009-11-20
NPR	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr	Hematology	Class 2	864.7280	2009-11-20
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2020-03-04
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2004-04-13
OMN	C. Difficile Nucleic Acid Amplification Test Assay	Microbiology	Class 1	866.2660	2011-12-01
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2024-12-10
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2025-02-20
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2012-12-11
OAI	Assay, Enterovirus Nucleic Acid	Microbiology	Class 2	866.3225	2007-06-08
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
OYX	Bcr/Abl1 Monitoring Test	Medical Genetics	Class 2	866.6060	2014-05-09
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
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
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
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
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
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-12-12
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2024-12-18
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2018-01-03
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-12-11
NIJ	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species	Microbiology	Class 2	866.1640	2024-12-11
OWD	Somatic Gene Mutation Detection System	Unknown	Class 3	N/A	2020-12-04
PEU	System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen	Microbiology	Class 2	866.3373	2013-12-19
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
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
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2010-12-14
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2010-12-14
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
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
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	2012-12-07
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2012-12-07
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2017-02-15
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	2023-11-02
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-11-02
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Immunology	Class 2	866.6010	2020-12-04
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2025-02-14
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-02-14
PEU	System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen	Microbiology	Class 2	866.3373	2024-12-11
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
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2020-12-05
NIA	Assay, Direct, Nucleic Acid Amplification, Influenza Virus	Microbiology	Class 1	866.3330	2020-03-04
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2023-11-10
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2009-11-20
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2020-03-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-11-29
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2016-11-29
QTP	Reagents, Monkeypox Virus Nucleic Acid.	Unknown	Class N	N/A	2023-02-13
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2022-11-30
NAH	System, Test, Tumor Marker, For Detection Of Bladder Cancer	Unknown	Class 3	N/A	2020-12-04
SBP	Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test	Microbiology	Class 2	866.3171	2024-07-02

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
3009613136	CEPHEID AB	SOLNA Stockholm, SE
3016838963	Cepheid	Lodi, CA, US

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-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0015-2014	Sekisui Diagnostics LLC	1	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
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 3004530258. Last updated year: 2026. Please use registration number 3004530258 when referencing this establishment in official correspondence.