# Intec Products, Inc. (Xiamen) · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Intec Products, Inc. (Xiamen) · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is HIV Home Test Kit; product code is 81 M - - TK Kit, Sample Collection, HIV; date published is 05/12/2014; address is 332 Xinguang Road , Industrial Areafujian Prov , Xiamen, Fujian CHINA, verified against its source on 2026-09-16.

- **Firm:** Intec Products, Inc. (Xiamen) _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** 332 Xinguang Road , Industrial Areafujian Prov , Xiamen, Fujian CHINA _(verified: appears in the quote below)_
- **Date published:** 05/12/2014 _(verified: appears in the quote below)_
- **Product code:** 81 M - - TK Kit, Sample Collection, HIV _(verified: appears in the quote below)_
- **Product:** HIV Home Test Kit _(verified: appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Intec Products, Inc. (Xiamen) Date Published : 05/12/2014 332 Xinguang Road , Industrial Areafujian Prov , Xiamen, Fujian CHINA 81 M - - TK Kit, Sample Collection, HIV Date Published: 05/12/2014 Desc: HIV Home Test Kit Notes: Class III

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).