Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016733849

FEI Number

3016733849

Entity Name

JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.

City/State/Country

Nantong Jiangsu, CN

Establishment Address

No.888, Zhujiang Road, Juegang Street, Rudong County, Life and Health Industrial Park of Rudong High-tech Zone, Nantong Jiangsu 226499, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. (Owner Number: 10084191)

Owner / Operator Contact Address

No.888, Zhujiang Road, Juegang Street, Rudong County, Life and Health Industrial Park of Rudong High-tech Zone, Nantong, CN-JS 226499, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) Adenovirus Antigen Detection Kit (Immunochromatography) Macro & Micro-Test Fluorescence Reader Macro & Micro-Test Fluorescence Immunoassay Analyzer Macro & Micro-Test LH Test Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography) Macro & Micro-Test HCG Preganancy Test Midstream Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit Macro & Micro-Test Viral DNA/RNA Kit Macro & Micro-Test Sample Release Reagent Macro & Micro-Test Automatic Nucleic Acid Extractor Group A Streptococcus Antigen Detection Kit (Immunochromatography) Group B Streptococcus Antigen Detection Kit (Immunochromatography)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GOB	Antigens, Ha (Including Ha Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2022-08-30
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2022-08-25
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2023-03-30
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2022-08-30
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-11-09
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-01-24
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2022-01-24
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2022-08-30

Official Correspondent

Licheng Liu

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Macro & Micro-Test Med-Tech 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
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

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
Z-0015-2014	Sekisui Diagnostics LLC	1	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016733849. Last updated year: 2026. Please use registration number 3016733849 when referencing this establishment in official correspondence.