# GEM TECHNOLOGY CO.,LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GEM TECHNOLOGY 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 "Drug Abuse Test" IVD kit; product code is 91 L - - AF Gas Chromatography, Methamphetamine; date published is 09/05/2017; address is NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA, verified against its source on 2026-09-16.

- **Firm:** GEM TECHNOLOGY 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:** NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA _(verified: appears in the quote below)_
- **Date published:** 09/05/2017 _(verified: appears in the quote below)_
- **Product code:** 91 L - - AF Gas Chromatography, Methamphetamine _(verified: appears in the quote below)_
- **Product:** "Drug Abuse Test" IVD kit _(verified: appears in the quote below)_
- **FDA notes:** The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown. _(verified: appears in the quote below)_

## What the source says

> GEM TECHNOLOGY CO.,LTD Date Published : 09/05/2017 NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA 91 L - - AF Gas Chromatography, Methamphetamine Date Published: 09/05/2017 Desc: "Drug Abuse Test" IVD kit Notes: The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown.

## 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/).