# Amoy Diagnostics Co. Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Amoy Diagnostics Co. Ltd. · 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 Mutation Detection Kit | Mutation Detection Kit; product code is 81 M - - VU Reagents, Specific, Analyte | 88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor; date published is 05/24/2013; address is 5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA, verified against its source on 2026-09-16.

- **Firm:** Amoy Diagnostics Co. Ltd. _(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:** 5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA _(verified: appears in the quote below)_
- **Date published:** 05/24/2013 _(verified: appears in the quote below)_
- **Product code:** 81 M - - VU Reagents, Specific, Analyte | 88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor _(verified: each item appears in the quote below)_
- **Product:** Mutation Detection Kit | Mutation Detection Kit _(verified: each item appears in the quote below)_
- **FDA notes:** Class III | class III _(verified: each item appears in the quote below)_

## What the source says

> Amoy Diagnostics Co. Ltd. Date Published : 05/24/2013 5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA 81 M - - VU Reagents, Specific, Analyte Date Published: 05/24/2013 Desc: Mutation Detection Kit Notes: Class III 88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor Date Published: 05/24/2013 Desc: Mutation Detection 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/).