HUNAN RUNMEI GENE TRCHNOLOGY COLTD · 89-08 · CHINA
For HUNAN RUNMEI GENE TRCHNOLOGY COLTD · 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 New Coronavirus COVID-19 Nucleic Acid Dectection Kit (Fluorescent RT-PCR- Method); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is Bldg 3 Rm 401 , 1048 Zhong Qing Road , Hunan, Hunan CHINA, verified against its source on 2026-09-16.
- Firm
- HUNAN RUNMEI GENE TRCHNOLOGY COLTD 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
- Bldg 3 Rm 401 , 1048 Zhong Qing Road , Hunan, Hunan CHINA verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- New Coronavirus COVID-19 Nucleic Acid Dectection Kit (Fluorescent RT-PCR- Method) verified
What the source says
HUNAN RUNMEI GENE TRCHNOLOGY COLTD Date Published : 11/24/2021 Bldg 3 Rm 401 , 1048 Zhong Qing Road , Hunan, Hunan CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: New Coronavirus COVID-19 Nucleic Acid Dectection Kit (Fluorescent RT-PCR- Method)
— 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.