Sansure Biotech Inc.

FDA Device Registration & Listing · Changsha Hunan, CN · Registration 3016619649

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
3016619649
FEI Number
3016619649
Entity Name
Sansure Biotech Inc.
City/State/Country
Changsha Hunan, CN
Establishment Address
No. 680, Lusong Road, Yuelu District, Changsha Hunan 410205, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sansure Biotech Inc. (Owner Number: 10077049)
Owner / Operator Contact Address
No. 680, Lusong Road, Yuelu District, Changsha, CN-HN 410205, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Q-Vera Prima 96 qPCR Instrument Q-Vera Pico 6X qPCR Instrument Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

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 2021-12-29
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0006-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Non-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 3016619649. Last updated year: 2026. Please use registration number 3016619649 when referencing this establishment in official correspondence.
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