Genetic Signatures Limited · 89-08 · AUSTRALIA
For Genetic Signatures Limited · 89-08 · AUSTRALIA, 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 AUSTRALIA; product is EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 01/21/2022; address is 7 Eliza St , Newtown, New South Wales AUSTRALIA, verified against its source on 2026-09-16.
- Firm
- Genetic Signatures Limited 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
- AUSTRALIA verified
- Address
- 7 Eliza St , Newtown, New South Wales AUSTRALIA verified
- Date published
- 01/21/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT) verified
What the source says
Genetic Signatures Limited Date Published : 01/21/2022 7 Eliza St , Newtown, New South Wales AUSTRALIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/21/2022 Desc: EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT)
— 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.