CEPHEID AB

FDA Device Registration & Listing · SOLNA Stockholm, SE · Registration 3009613136

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
3009613136
FEI Number
3009613136
Entity Name
CEPHEID AB
City/State/Country
SOLNA Stockholm, SE
Establishment Address
Rontgenvagen 5, SOLNA Stockholm SE-171 54, SE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
CEPHEID (Owner Number: 9062742)
Owner / Operator Contact Address
904 CARIBBEAN DRIVE, --, Sunnyvale, CA 94089, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Xpert Xpress GBS Xpert Urine Specimen Collection Kit Xpert Swab Specimen Collection Kit Xpert CT/NG Xpert Vaginal/Endocervical Specimen Collection Kit Xpert Xpress Flu Xpert GI Panel Xpert Xpress CoV-2/Flu/RSV plus Xpert Xpress Strep A Xpert HCV Xpert Xpress Flu/RSV Xpert Xpress Flu/RSV Xpert® Xpress CoV-2 plus Xpert Xpress CoV-2/Flu/RSV plus Xpert Nasal Sample Collection Kit Xpert Nasopharyngeal Sample Collection Kit XPERT Xpress Flu Xpert Nasopharyngeal Sample Collection kit Xpert Xpress Flu Xpert Nasal Sample Collection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2023-11-02
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2019-05-23
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2019-05-23
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Microbiology Class 2 866.3393 2019-05-23
QBD Microbial Nucleic Acid Storage And Stabilization Device Microbiology Class 2 866.2950 2019-05-23
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2017-02-15
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Microbiology Class 2 866.3990 2026-01-28
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2025-05-21
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Microbiology Class 2 866.2680 2017-09-26
SBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test Microbiology Class 2 866.3171 2024-07-02
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
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Microbiology Class 2 866.3981 2025-02-20
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
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 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
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2018-01-03
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2024-12-10

Official Correspondent

Somesh Lalithraj

US Agent Details

Somesh Lalithraj Business: CEPHEID Email: somesh.lalithraj@cepheid.com Phone: (408) 2427416

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
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-0042-2025 Luminex Molecular Diagnostics Inc 2
NxTAG Respiratory Pathogen Panel, REF: I051C0447

Similar Registrations

Registration Number Establishment Name Location
3004530258 CEPHEID Sunnyvale, CA, US
3026312356 SUZHOU TIANLONG BIOTECHNOLOGY CO., LTD. Suzhou Jiangsu, CN
3016838963 Cepheid Lodi, CA, US
2024800 Hologic, Inc. SAN DIEGO, CA, US
3012918440 Meridian Bioscience Canada Inc. Quebec, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009613136. Last updated year: 2026. Please use registration number 3009613136 when referencing this establishment in official correspondence.
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