Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013540184

FEI Number

3013540184

Entity Name

XIAMEN ZEESAN BIOTECH CO., LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

No. 884-1 and 884-2 Lianting Road, (Xiang An) Industrial Area, Torch High-Tech Zone, Xiamen Fujian 361101, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Xiamen Zeesan Biotech Co., Ltd (Owner Number: 10060382)

Owner / Operator Contact Address

No. 884-1 and 884-2 Lianting Road, (Xiang An) Industrial Area, Torch High-Tech Zone, Xiamen, CN-FJ 361101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Real-Time PCR System, model: SLAN-96S, SLAN-96P, SLAN-48P ZEESAN, Sanity 2 System, model: Sanity2 ZEESAN, Respiratory Pathogen Panel (RPP 12D), 24 Tests/Kit, 48 Tests/Kit ZEESAN, CBF?-MYH11 Detection Kit, Model 20 Tests/Kit ZEESAN, Sanity-2 Respiratory Pathogen Panel (RPP4), Model 24 Tests/Kit ZEESAN, Sanity-2 MDR-TB Test Kit, Model 24 Tests/Kit ZEESAN, Sanity-2 Respiratory Pathogen Panel (RPP12), Model 24 Tests/Kit ZEESAN, RT Reagent Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.617 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, PML-RAR? S Detection Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Test Kit (Sanity 2), 24 Tests/Kit, 48 Tests/Kit ZEESAN, MeltPro® Low Risk HPV Genotyping Assay, 48 Tests/Kit ZEESAN, Sanity-2 Respiratory Pathogen Panel (RPP3), Model 24 Tests/Kit ZEESAN, SARS-CoV-2 Mutation Panel (Sanity 2), 24 Tests/Kit, 48 Tests/Kit ZEESAN, Leukemia Fusion Genes (Q55) Screening Probe Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.1.7 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, BCR-ABL1 Kinase Domain Mutation Screening Kit, Model 20 Tests/Kit ZEESAN, PML-RAR? Genotyping Kit, Model 20 Tests/Kit ZEESAN, MTB/RIF Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP4D), Model 48 Tests/Kit ZEESAN, High Risk HPV Genotyping Assay (MMCA), 48 Tests/Kit ZEESAN, Sanity-2 Monkeypox Virus Test Kit, Model 24 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.351 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, SARS-CoV-2 Mutation Panel, 24 Tests/Kit, 48 Tests/Kit ZEESAN, Sanity 2 Respiratory Pathogen Panel, 12 Tests/Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, PML-RAR? V Detection Kit, Model 20 Tests/Kit ZEESAN, PML RAR? L Detection Kit, Model 20 Tests/Kit ZEESAN, Sanity 2-MTB/MDR Test Kit, Model 24 Tests/Kit ZEESAN, MDR-TB Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP19D), Model 48 Tests/Kit ZEESAN, Mycobacteria Identification Kit (Sanity 2) , Model 24 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP17D), Model 48 Tests/Kit ZEESAN, Leukemia Fusion Genes (Q51) Screening Kit, Model 20 Tests/Kit ZEESAN, Mycobacteria Identification Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB/SL Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, STI-15 Detection Kit, Model 48 Tests/Kit ZEESAN, SARS-CoV-2 Variant P.1 Identification Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, Leukemia Fusion Genes (Q30) Screening Kit ZEESAN, BCR-ABL1 p190 Detection Kit, Model 20 Tests/Kit ZEESAN, Monkeypox Virus Test Kit, Model 48 Tests/Kit ZEESAN, MDR-TB Test Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, High Risk HPV Genotyping Kit (Sanity 2), 24 Tests/Kit ZEESAN, MTB Test Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, MTB/STR Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB Test Kit, Model 48 Tests/Kit ZEESAN, MTB/FQ Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB/MDR Test Kit (Sanity 2), Model 24 Tests/Kit ZEESAN, Sanity-2 Mycobacteria Identification Kit, Model 24 Tests/Kit ZEESAN, Respiratory Pathogen Panel (RPP3D) , Model 48 Tests/Kit ZEESAN, MTB/INH Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, MTB/PZA Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, Sanity 2-MTB Test Kit, Model 24 Tests/Kit ZEESAN, WT1 Detection Kit , Model 20 Tests/Kit ZEESAN, AMLl-ETO Detection Kit, Model 20 Tests/Kit ZEESAN, BCR-ABL1 Genotyping Kit, Model 20 Tests/Kit ZEESAN, Leukemia Fusion Genes (Ph like) Screening Probe Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Test Kit, 24 Tests/Kit, 48 Tests/Kit ZEESAN, BCR-ABL1 p210 Detection Kit, Model 20 Tests/Kit ZEESAN, SARS-CoV-2 Variant B.1.617 Identification Kit (Sanity 2), 24 Tests/Kit, 48 Tests/Kit ZEESAN, MTB/EMB Test Kit (MMCA), Model 48 Tests/Kit ZEESAN, SARS-CoV-2 Test Kit (Real-time PCR), 48 Test/Kit Disposable Sampling Swab, Type A-01, Type A-02, Type A-03, Type A-04, Type A-05

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-05-19
OTU	Research Use Only/Pathology	Unknown	Class N	N/A	2021-08-05
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2021-01-29
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-04-18

Official Correspondent

Long Han

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Xiamen Zeesan Biotech Co., Ltd

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-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013540184. Last updated year: 2026. Please use registration number 3013540184 when referencing this establishment in official correspondence.