Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012259842

FEI Number

3012259842

Entity Name

XIAN TIANLONG SCIENCE AND TECHNOLOGY CO., LTD.

City/State/Country

Xi'an Shaanxi, CN

Establishment Address

No.4266, Shanglin Road, Weiyang District, Xi'an Shaanxi 710021, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xian Tianlong Science and Technology Co., Ltd. (Owner Number: 10075325)

Owner / Operator Contact Address

No.4266, Shanglin Road, Weiyang District, Xian, CN-SN 710021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CareStart MDx Real-Time PCR System All-in-one Molecular Diagnosis System-Panall 8000 Adapt 48, Adapt 96 Real-time PCR System (Gentier 96E, Gentier 96T, Gentier 96R, Gentier 96C, Gentier 96S) Real-time PCR System (Gentier mini, Gentier mini+) Multichannel Fluorescence Quantitative Analyzer (Fascan 48E/48S/16E/16S) Real-time PCR System (Gentier X3E, Gentier X3R, Gentier X3S, Gentier X3C) Real-time PCR System (Gentier 48E, Gentier 48R) Real-time PCR System - Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R Fully Automated Molecular Testing System POCT - iGenebox 3A Nucleic Acid Extraction Kit (For Universal Pathogen DNA and RNA) - T849H-T850H Nucleic Acid Extraction Kits Viral DNA and RNA Extraction Kit (Panall 8000 MD System, pre-filled) Nucleic Acid Extraction Kit (For Amniotic Fluid Extraction) -T201H/T202H/T321H Nucleic Acid Extraction Kit (For Animal Tissues Genomic DNA Extraction) -T093H Viral DNA and RNA Extraction Kit (Panall 8000 MD System, pre-filled) -T373H Viral DNA and RNA Extraction Kit -T014H/T016H/T060H Viral DNA and RNA Extraction Kit -T041H Nucleic Acid Extraction Kit (Panall 8000 MD System, Pre-filled) -T813H Nucleic Acid Extraction Kit (For Blood RNA Extraction) -T533H/T534H Nucleic Acid Extraction Kit (For Bacteria Genomic DNA Extraction) -T529H/T530H Nucleic Acid Extraction Kit (For HPV DNA Extraction) -T113H/T114H/T115H Whole Blood Genomic DNA Extraction Kit (SMA-GeneFlex) -T509H Viral DNA and RNA Extraction Kit -T338H/T528H Nucleic Acid Extraction Kit (For HCMV/EB DNA Extraction) -T111H/T112H/T123H Viral DNA and RNA Extraction Kit -T392H Nucleic Acid Extraction Kit (For Bacteria Genomic DNA Extraction) -T131H/T132H/T134H Animal Virus DNA and RNA Extraction Kit -T070H/T071H/T072H/T073H/T074H Nucleic Acid Extraction Kit (For Free Circulating DNA Extraction) -T171H/T172H Viral DNA and RNA Extraction Kit -T505H/T506H/T507H/T508H Nucleic Acid Extraction Kit (For Plasmid DNA Extraction) -T901H/T936H Nucleic Acid Extraction Kit (For Pathogen DNA and RNA Extraction) -T510H/T511H/T512H/T513H Viral DNA and RNA Extraction Kit (Panall 8000 MD System, pre-filled) -T340H Nucleic Acid Extraction Kit (For Buccal Swab DNA Extraction) -T191H/T192H Animal Virus DNA and RNA Extraction Kit (GeneFlex) -T079H/T080H Whole Blood Genomic DNA Extraction Kit (For SMA Detection Use) -T372H/T376H/T516H Nucleic Acid Extraction Kit (For HCMV/EB DNA Extraction-GeneFlex) -T524H/T525H/T526H/T527H Nucleic Acid Extraction Kit (For FFPE DNA Extraction, Spin-Column Method) -T163H Viral DNA and RNA Extraction Kit -T038H/T322H/T323H/T324H Viral DNA and RNA Extraction Kit -T183H Nucleic Acid Extraction Kit (For Meningitis & Febrile Illness Test - Panall 8000) - T847H Nucleic Acid Extraction Kit (For FFPE Genomic DNA Extraction Kit) -T161H/T162H/T165H Nucleic Acid Extraction Kit (For Blood Screening -Panall 8000) -T552H Animal Virus DNA and RNA Extraction Kit (PLUS) -T800H/T801H/T802H Nucleic Acid Extraction Kit (For Dried Blood Spot Genomic DNA Extraction) -T150H/T151H/T152H/T153H Viral DNA and RNA Extraction Kit -T518H Viral DNA and RNA Extraction Kit (For Environmental detection use - GeneFlex) -T806H/T807H/T808H Whole Blood Genomic DNA Extraction Kit -T146H/T147H/T148H/T149H Nucleic Acid Extraction Kit -T390H Whole Blood Genomic DNA Extraction Kit -T389H Viral DNA and RNA Extraction Kit -T049H/T050H/T051H/T052H Nucleic Acid Extraction Kit (For HIV/HBV/HCV - Panall 8000) - T562H Nucleic Acid Extraction Kit (For Blood RNA Extraction) -T546H/T547H Nucleic Acid Extraction Kit (For TB-DNA Extraction) -T135H/T136H/T137H Nucleic Acid Extraction Kit (For Free Circulating DNA Extraction, 2-4 mL) -T531H/T532H Nucleic Acid Extraction Kit (For Stool DNA and RNA Extraction) -T180H/T181H/T182H Viral DNA and RNA Extraction Kit -T325H Nucleic Acid Extraction Kit (For Viral DNA and RNA-Panall 8000) -T819H Viral DNA and RNA Extraction Kit -T108H Nucleic Acid Extraction Kit (For Plant Tissues Genomic DNA Extraction) -T084H/T085H/T087H Nucleic Acid Extraction Kit (For Plasmid DNA Extraction-GeneFlex) -T839H/T840H Nucleic Acid Extraction Kit (GeneRotex24) - T557H Viral DNA and RNA Extraction Kit -T393H Nucleic Acid Extraction Kit (For Dried Blood Spot Genomic DNA Extraction- SMA) -T390H Viral DNA and RNA Extraction Kit -T339H Nucleic Acid Extraction Kit (For Free Circulating DNA Extraction, Spin-Column method) -173H Nucleic Acid Extraction Kit (For HPV DNA Extraction PLus) - T519H/T521H/T522H/T523H Nucleic Acid Extraction Kit (For Enteropathogen DNA and RNA-Panall 8000) -T838H Nucleic Acid Extraction Kit (For Viral DNA and RNA) - T548H/T549H/T550H/T551H Sample Collection Set Sample Collection Set- T500H PCR Thermal Cycler-Genesy 96T Automated Liquid Handling System-PANA S401, PANA S201 Automatic Sample Processing System-GeneMix 48, GeneMix Pro

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	2020-09-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-06-11
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2020-06-11
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-02-22
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-03-18

Official Correspondent

Yu Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Xian Tianlong Science and Technology 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-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012259842. Last updated year: 2026. Please use registration number 3012259842 when referencing this establishment in official correspondence.