GEM TECHNOLOGY CO.,LTD · 89-08 · CHINA
For GEM TECHNOLOGY CO.,LTD, 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 "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 2026-09-30.
- Firm
- GEM TECHNOLOGY CO.,LTD 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
- NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA verified
- Date published
- 09/05/2017 verified
- Product code
- 91 L - - AF Gas Chromatography, Methamphetamine verified
- Product
- "Drug Abuse Test" IVD kit verified
- FDA notes
- The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown. verified
What the source says
GEM TECHNOLOGY CO.,LTD Date Published : 09/05/2017 NO. 20 BOSONG ROAD ZHEN , HENAN, 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
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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