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Sign in to claim this brandInTec 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
- —
- —
- [email protected]
- Phone
- +86 592 680 7228
- PRRC Contact
- Nicole Zhang
- EUDAMED SRN
- CN-MF-000023625
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (84)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ONE STEP Phencyclidine (PCP) Test | ITP06009-DS50 | EUDAMED | IVD General | Active |
| One Step Multi-7 DOA Test | ITP06106-DT20 | EUDAMED | IVD General | Active |
| ONE STEP Multi-8 DOA Test | ITP06107-DT20 | EUDAMED | IVD General | Active |
| ONE STEP Multi-4 DOA Test | ITP06103-DT20 | EUDAMED | IVD General | Active |
| ONE STEP Buprenorphine (BUP) Test | ITP06013-DS50 | EUDAMED | IVD General | Active |
| ONE STEP Tramadol (TRA) Test | ITP06014-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Buprenorphine (BUP) Test | ITP06013-TC40 | EUDAMED | IVD General | Active |
| One Step Multi-7 DOA Test | ITP06106-DT10 | EUDAMED | IVD General | Active |
| AQ+Rapid SARS-CoV-19/ Flu Combo Test | ITP16050-TC1 | EUDAMED | IVD General | Active |
| Rapid Flu A Test | ITP081001-TC20 | EUDAMED | IVD General | Active |
| AQ+Rapid SARS-CoV-19/ Flu Combo Test | ITP16050-TC25 | EUDAMED | IVD General | Active |
| ONE STEP Multi-5 DOA Test | ITP06104-DT20 | EUDAMED | IVD General | Active |
| ONE STEP Ecstasy (MDMA) Test | ITP06010-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Multi-8 DOA Test | ITP06107-DT10 | EUDAMED | IVD General | Active |
| Rapid Anti-HEV-IgM Test | ITP091101-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Methamphetamine (MET) Test | ITP06005-DS50 | EUDAMED | IVD General | Active |
| ONE STEP Multi-9 DOA Test | ITP06108-DT10 | EUDAMED | IVD General | Active |
| ONE STEP Benzodiazepines (BZO) Test | ITP06006-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Tramadol (TRA) Test | ITP06014-DS50 | EUDAMED | IVD General | Active |
| ONE STEP Cocaine (COC) Test | ITP06004-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Opiate (OPI/Morphine) Test | ITP06002-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Methadone (MTD) Test | ITP06008-DS50 | EUDAMED | IVD General | Active |
| ONE STEP Multi-11 DOA Test | ITP06110-DT10 | EUDAMED | IVD General | Active |
| Rapid Anti-H.Pylori Test | ITP10002-TC40 | EUDAMED | IVD General | Active |
| Rapid Rotavirus Test | ITP14001-TC20 | EUDAMED | IVD General | Active |
| ONE STEP Multi-3 DOA Test | ITP06102-DT20 | EUDAMED | IVD General | Active |
| ONE STEP Pregnancy (hCG) Test | ITP04002-DS50 | EUDAMED | IVD General | Active |
| 69361558covid19-Ag-Be**x5 | ITP16013-TC25- | EUDAMED | IVD General | Active |
| Rapid Anti-HEV-IgM Test | ITP091101-DS50 | EUDAMED | IVD General | Active |
| AQ+ COVID-19 Ag Rapid Test | ITP16042-TC25- | EUDAMED | IVD General | Active |
| ONE STEP Cannabinoids (THC) Test | ITP06003-DS50 | EUDAMED | IVD General | Active |
| One Step Amphetamine (AMP) Test | ITP06001-TC40 | EUDAMED | IVD General | Active |
| ONE STEP Benzodiazepines (BZO) Test | ITP06006-DS50 | EUDAMED | IVD General | Active |
| ONE STEP Barbiturates (BAR) Test | ITP06007-DS50 | EUDAMED | IVD General | Active |
| Rapid Anti-H.Pylori Test | ITP10212-DS50 | EUDAMED | IVD General | Active |
| ONE STEP Malaria(p.f/p.v) Tri-line Test | ITP11003-TC25 | EUDAMED | IVD General | Active |
| ONE STEP Malaria(p.f.) Test | ITP11002-TC25 | EUDAMED | IVD General | Active |
| ONE STEP Multi-12 DOA Test | ITP06111-DT10 | EUDAMED | IVD General | Active |
| ONE STEP H. pylori Ag Test | ITP10003-TC20 | EUDAMED | IVD General | Active |
| ONE STEP Barbiturates (BAR) Test | ITP06007-TC40 | EUDAMED | IVD General | Active |
| AQ+ COVID-19 Ag Rapid Test | ITP16042-TC25 | EUDAMED | IVD General | Active |
| ONE STEP H. pylori Ag Test | ITP10213-TC20 | EUDAMED | IVD General | Active |
| AQ+ COVID-19 Ag Rapid Test | ITP16044-TC25 | EUDAMED | IVD General | Active |
| ONE STEP Opiate (OPI/Morphine) Test | ITP06002-DS50 | EUDAMED | IVD General | Active |
| W0105040601 | ITP14002-TC20 | EUDAMED | IVD General | Active |
| ONE STEP Multi-2 DOA Test | ITP06101-DT20 | EUDAMED | IVD General | Active |
| ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test | ITP71002-DS50 | EUDAMED | IVD General | Active |
| AQ+ COVID-19 Ag Rapid Test | ITP16042-TC5 | EUDAMED | IVD General | Active |
| ONE STEP Cannabinoids (THC) Test | ITP06003-DS50 | EUDAMED | IVD General | Active |
| COVID-19/FluA&B/RSV Ag Combo Rapid Test | ITP182603-TC25 | EUDAMED | IVD General | Active |
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