Genetic Signatures Limited · 89-08 · AUSTRALIA
For Genetic Signatures Limited, import alert is 89-08; country is AUSTRALIA; 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 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 2026-09-30.
- 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
— 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: 01/21/2022 Desc: EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html