Intec Products, Inc. (Xiamen) · 89-08 · CHINA
For Intec Products, Inc. (Xiamen), import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
81 M - - TK Kit, Sample Collection, HIV Date Published: 05/12/2014 Desc: HIV Home Test Kit Notes: Class III
— all from 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.