FDA Registration
Active
🇨🇳 China
XIAN TIANLONG SCIENCE AND TECHNOLOGY CO., LTD.
Reg #: 3012259842
·
FEI: 3012259842
·
Expires 2026
Products
8
Proprietary Names
95
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- XIAN TIANLONG SCIENCE AND TECHNOLOGY CO., LTD.
- Registration Number
- 3012259842
- FEI Number
- 3012259842
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.4266, Shanglin Road, Weiyang District
- City
- Xi'an Shaanxi
- Country
- CN
Owner / Operator
- Firm Name
- Xian Tianlong Science and Technology Co., Ltd.
- Operator Number
- 10075325
- Address
- No.4266, Shanglin Road, Weiyang District
- City
- Xian
- State
- Shaanxi
- Postal Code
- 710021
- Country
- CN
- Correspondent
- Yu Wang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2020-09-14 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2020-06-11 |
| Preservative, Cytological | LEA | Class 1 | Pathology | No | 2020-06-11 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2022-02-22 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2021-03-18 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2023-04-23 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2020-09-14 |
| Culture Media, Non-Selective And Differential | JSH | Class 1 | Microbiology | No | 2022-02-23 |
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
Agglutination Automated Detection System (RBT 320)
Automatic Nucleic Acid Workstation-PANA 4800S, PANA 9600S, PANA 9600X
Automatic Nucleic Acid Extractor-GeneFlex 16,GeneFlex 32, GeneFlex 48, GeneFlex 96, GeneFlex 192
Automatic Nucleic Acid Extractor- GeneRotex 24
Automatic Nucleic Acid Extractor-GeneRotex 96, GeneRotex 48
Nucleic Acid Extractor-NP968-C, NP968-S
Automatic Nucleic Acid Extractor-Libex
Automatic Nucleic Acid Workstation - PANA 3200S, PANA 3200S+
Automatic Nucleic Acid Extractor-Npex 192
Automated Nucleic Acid Extraction System - Aurora PANA X6
Liquswab Free BP - A035H
ATP Test Swab - A017H, A010H, A011H
Biolum Portable ATP Monitoring System Pro - Biolum Pro
Lyophilized ATP Test Swab - Lyophilized Quick Swab
Lyophilized ATP Liquid Swab (Total) - A031H
Calibration Verification for ATP - EternalLight-H
Biolum Portable ATP Hygiene Monitoring System - Biolum Plus
Liquswab Total BP - A034H
Biolum Portable ATP Hygiene Monitoring System - Biolum
Quickswab BP - A033H
Lyophilized ATP Liquid Swab (Free) - A032H
Establishment Types
Manufacture Medical Device