Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014255036

FEI Number

3014255036

Entity Name

JILIN TEST BIO-ELECTRON CO.,LTD

City/State/Country

Changchun Jilin, CN

Establishment Address

No. 1165 Ya 'an Road, Beihu Science and Technology Development Zone, Changchun Jilin 130000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jilin Test Bio-Electron Co.,Ltd (Owner Number: 10056551)

Owner / Operator Contact Address

No. 1165 Ya 'an Road, Beihu Science and Technology Development Zone, Changchun, CN-JL 130000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nitrite test strips urinalysis reagent test strips, free radical test strips ketone test strips Protein test strips PH test strips, Easy @ Home Feminine Vaginal pH Test Strip Lead test swab, Lead test kit (colloidal gold) Water test kit (Chlorine, pH, Alkalinity, Cyanuric Acid, Hardness, Nitrate, Nitrite, Carbonate, Lead, Phosphate, Water test strips, Oil quality test strips, Chlorine test strips, Food test strips, Water test equipment, Soil test kit, Manganese, Nickel, Tin, Cobalt, QAC), Mold Test Kit Bromine, Fluoride, Arsenic, COD, Ammonia, Copper, Phosphorus, Iron, Chromium, Nitrogen, Zinc, MPS, H2O2, PHMG, UTI test strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2019-02-09
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2017-12-20
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2017-12-20
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2019-02-09
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2017-12-20
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2024-07-05
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2017-12-20
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2017-12-20

Official Correspondent

kuizi Wang

US Agent Details

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

Related Public Records

Same Entity

Jilin Test Bio-Electron 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
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400
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.

Similar Registrations

Registration Number	Establishment Name	Location
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3024171133	Changchun LYZ Technology Co.,LTD	Changchun City Jilin, CN
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014255036. Last updated year: 2026. Please use registration number 3014255036 when referencing this establishment in official correspondence.