Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031915160

FEI Number

3031915160

Entity Name

AVE SCIENCE & TECHNOLOGY CO., LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

AVE Medical Technology Park, No.26 Fuling Road Xueshi Community, Yuelu District, Changsha Hunan 410208, CN

Establishment Type(s)

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

Owner / Operator

AVE Science & Technology Co., Ltd (Owner Number: 10091279)

Owner / Operator Contact Address

AVE Medical Technology Park, No.26 Fuling Road Xueshi Community, Yuelu, District, 410208 Changsha, Hunan Province, PEOPLE REPUBLIC OF CHINA, Changsha, CN-HN 410208, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lactoferrin Rapid Test Kit (Colloidal Gold) Luteinizing Hormone Rapid Test Kit (Colloidal Gold) Gynecological Analysis Staining Solution Gram Staining Solution Wright's Giemsa Staining Solution Urine Ketone Test Strips Rotavirus Antigen Group A and Adenovirus Antigen Rapid Test Kit (Colloidal Gold) Rotavirus Antigen Group A Rapid Test Kit (Colloidal Gold) Adenovirus Antigen Rapid Test Kit (Colloidal Gold) Urine Specific Gravity Test Strips Urine Nitrite Test Strips Diluent Buffer Cleanser Female Lactic Acid Test Strips Insulin-like Growth Factor Binding Protein 1 Rapid Test Kit (Colloidal Gold) Helicobacter pylori Antigen Rapid Test Kit(Colloidal Gold) Urine Microalbuminuria Test Strips Urine Leukocytes Test Strips Urine Urobilinogen Test Strips Urine Ascorbic Acid Test Strips Urine Bilirubin Test Strips Fully Automatic Slide Stainer Urine Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2025-01-11
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-08-08
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2025-01-11
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-08-08
GOB	Antigens, Ha (Including Ha Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2024-08-08
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2025-01-11
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-08-08
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-01-11
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2025-01-11
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	Class 1	862.1550	2024-08-08
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2025-01-11
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2025-01-11
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-08-08
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2025-01-11
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2025-01-11
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2025-01-11
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2025-01-11
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-08-08

Official Correspondent

JIE LIU

US Agent Details

Bryan Wong Business: PUREVISION AI, INC. (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

AVE Science & Technology 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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031915160. Last updated year: 2026. Please use registration number 3031915160 when referencing this establishment in official correspondence.