Intec Products, Inc. (Xiamen) · 89-08 · CHINA
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
- 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
- Address
- 332 Xinguang Road , Industrial Areafujian Prov , Xiamen, Fujian CHINA verified
- Date published
- 05/12/2014 verified
- Product code
- 81 M - - TK Kit, Sample Collection, HIV verified
- Product
- HIV Home Test Kit verified
- FDA notes
- Class III verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.