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InTec PRODUCTS, INC.

China·CN-MF-000023625

Last updated September 18, 2026

About

FOUNDED IN 1989 AS A HIGH-TECH ENTERPRISE SPECIALIZED IN THE DEVELOPMENT, PRODUCTION AND MARKETING OF IN VITRO DIAGNOSTIC PRODUCTS. AS ONE OF THE OLDEST IVD ENTERPRISES IN THE COUNTRY, THE COMPANY RELIES ON THE DEPTH OF IMMUNOLOGICAL DETECTION TECHNIQUES FOR INFECTIOUS DISEASES, WHICH FORM THE CORE OF PACT AND ENZYMES, WITH A FOCUS ON THE DEVELOPMENT OF THE OPERATIONAL LAYOUT OF PRODUCTS SUCH AS BIOCHEMICAL, CHEMICAL LIGHTING AND MOLECULAR DIAGNOSTICS。

Translated from the manufacturer's own website. Source

What InTec PRODUCTS, INC. makes

The company manufactures rapid in vitro diagnostic (IVD) tests for drug detection and infectious disease screening. Its portfolio includes single-use lateral flow assays for substances like phencyclidine (PCP), buprenorphine, tramadol, and multi-analyte tests for drugs of abuse (DOA). It also produces point-of-care tests for respiratory pathogens, such as SARS-CoV-19 and influenza A, in both standalone and combined formats.

These devices fall under EU IVD Annex II List A and General classification categories, and they are registered in the EUDAMED database. The company is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does InTec PRODUCTS, INC. manufacture?

InTec PRODUCTS, INC. specializes in rapid in vitro diagnostic (IVD) tests. Their portfolio includes single-use lateral flow assays for detecting drugs of abuse (such as phencyclidine, buprenorphine, and tramadol) and multi-analyte tests for screening multiple substances simultaneously. Additionally, they produce point-of-care tests for infectious diseases, including standalone and combined formats for detecting SARS-CoV-19 and influenza A.

Where is InTec PRODUCTS, INC. based?

InTec PRODUCTS, INC. is based in China. The company’s headquarters and operations are located within the country, where it develops, produces, and markets its IVD products.

Which regulatory registries list InTec PRODUCTS, INC.’s devices?

InTec PRODUCTS, INC.’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This ensures transparency and traceability of their products under EU regulatory frameworks.

How are InTec PRODUCTS, INC.’s devices classified under EU regulations?

InTec PRODUCTS, INC.’s devices fall under EU IVD Annex II List A and General classification categories. Annex II List A applies to higher-risk IVDs (e.g., those detecting infectious agents or drugs of abuse), while General classification covers lower-risk devices. Classification determines regulatory requirements, such as conformity assessment procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: China
Address: 332 Xinguang Road, Xinyang Industrial Area,Haicang, , Xiamen, China
Website: www.asintec.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 592 680 7228
PRRC Contact: Nicole Zhang
EUDAMED SRN: CN-MF-000023625
FDA FEI Number: —
DUNS Number: —

Catalogue (84)

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Device	Model / Reference	Registries	Class	Status
One Step α-Fetoprotein (AFP) Test	ITP12002-TC40	EUDAMED	IVD General	Active
Rapid Anti-H.Pylori Test	ITP10002-DS50	EUDAMED	IVD General	Active
AQ+ COVID-19 Ag Rapid Test	ITP16042-TC1	EUDAMED	IVD General	Active
ONE STEP Tricyclic Antidepressants (TCA) Test	ITP06011-TC40	EUDAMED	IVD General	Active
AQ+ COVID-19 Ag Rapid Test	ITP16044-TC25-	EUDAMED	IVD General	Active
ONE STEP Multi-6 DOA Test	ITP06105-DT20	EUDAMED	IVD General	Active
ONE STEP Ketamine (KAN) Test	ITP06012-TC40	EUDAMED	IVD General	Active
One Step Amphetamine (AMP) Test	ITP06001-DS50	EUDAMED	IVD General	Active
ONE STEP Multi-10 DOA Test	ITP06109-DT10	EUDAMED	IVD General	Active
Rapid Flu A/B Test	ITP081003-TC20	EUDAMED	IVD General	Active
ONE STEP Ecstasy (MDMA) Test	ITP06010-DS50	EUDAMED	IVD General	Active
Rapid Malaria Test (P.f/Pan)	ITP11005-TC40	EUDAMED	IVD General	Active
ONE STEP H. pylori Ag Test	ITP10003-DS50	EUDAMED	IVD General	Active
Rapid Rota-Adenovirus Combo Test	ITP14003-TC20	EUDAMED	IVD General	Active
ONE STEP Multi-9 DOA Test	ITP06108-DT20	EUDAMED	IVD General	Active
ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test	ITP71002	EUDAMED	IVD General	Active
ONE STEP Anti-HIV (1&2) Test	ITP02152-TC40	EUDAMED	IVD Annex II List A	Active
One Step Dengue NS1 Ag Test	ITP71003-TC40	EUDAMED	IVD General	Active
ONE STEP H. pylori Ag Test	ITP10003-TC20	EUDAMED	IVD General	Active
Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test	ITP71004-TC20	EUDAMED	IVD General	Active
ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST	ITP03004-TC40	EUDAMED	IVD General	Active
ONE STEP Troponin I Test	ITP08001-TC40	EUDAMED	IVD General	Active
Rapid Anti-TB (Mycobacterium Tuberculosis) Test	ITP09002-DS50	EUDAMED	IVD General	Active
Rapid Anti-TB (Mycobacterium Tuberculosis) Test	ITP09002-TC40	EUDAMED	IVD General	Active
Rapid Anti-HCV Test	ITP01153-TC40	EUDAMED	IVD Annex II List A	Active
Rapid FOB Test	ITP13001-TC20	EUDAMED	IVD General	Active
Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test	ITP71004-TC25	EUDAMED	IVD General	Active
ONE STEP H. pylori Ag Test	ITP10003-DS50	EUDAMED	IVD General	Active
Rapid Anti-HCV Test	ITP01152-TC40	EUDAMED	IVD Annex II List A	Active
Rapid FOB Test	ITP13001-DS50	EUDAMED	IVD General	Active
ONE STEP Myoglobin/CK-MB-cTnI Combo TEST	ITP08101-TC20	EUDAMED	IVD General	Active
Rapid Rota-Adenovirus Combo Test	ITP14003-TC20	EUDAMED	IVD General	Active
ONE STEP Anti-HIV (1&2) Test	ITP02153-TC10	EUDAMED	IVD Annex II List A	Active
Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test	ITP71004-TC10	EUDAMED	IVD General	Active

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