HUNAN RUNMEI GENE TRCHNOLOGY COLTD · 89-08 · CHINA
For HUNAN RUNMEI GENE TRCHNOLOGY COLTD, 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 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 2026-09-30.
- 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
— 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 and Product
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)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html