PROMEDICAL EQUIPMENT PTY LTD · 89-08 · AUSTRALIA
For PROMEDICAL EQUIPMENT PTY LTD · 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 COVID-19 Rapid Test | COVID-19 Rapid Test | COVID-19 Rapid Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2020; address is 5-22 Alexandra Pl , Murarrie, Queensland AUSTRALIA, verified against its source on 2026-09-16.
- Firm
- PROMEDICAL EQUIPMENT PTY 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
- AUSTRALIA verified
- Address
- 5-22 Alexandra Pl , Murarrie, Queensland AUSTRALIA verified
- Date published
- 06/22/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- COVID-19 Rapid Test | COVID-19 Rapid Test | COVID-19 Rapid Test each item verified
What the source says
PROMEDICAL EQUIPMENT PTY LTD Date Published : 06/22/2020 5-22 Alexandra Pl , Murarrie, Queensland AUSTRALIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 Rapid Test
— 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.