HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3017231634

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
3017231634
FEI Number
3017231634
Entity Name
HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
#139 10th Street (East), Hangzhou Economic and Technology Development Zone, Hangzhou Zhejiang 310018, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. (Owner Number: 10078538)
Owner / Operator Contact Address
#139 10th Street (East), Hangzhou Economic and Technology Development Zone, Hangzhou, CN-ZJ 310018, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231027
PMA Number
N/A

All Registered Proprietary Names

OC-Light S FIT KaiBiLi Saliva Collection Kit Disposable sampling swab Genesis Sampling Swab KaiBiLi Extended ViralTrans Saline KaiBiLi Extended ViralTrans PBS Vaginal Swab Kit KaiBiLi Extended ViralTrans

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2024-12-30
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2021-04-22
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-12-03
JSG Culture Media, Non-Selective And Non-Differential Microbiology Class 1 866.2300 2020-10-26
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2024-08-07

Official Correspondent

Reuben Weng

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K162333 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step Fecal Occult Blood (FOB) Test 2017-05-14
K880142 Hardy Media TSA W/LEC. & TWEEN. 80 1988-03-30
K914894 Microtest VIRAPURE, CHLAMYPURE AND MYCOPURE 1991-12-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017231634. Last updated year: 2026. Please use registration number 3017231634 when referencing this establishment in official correspondence.
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