MELBOURNE BIOTECH · 89-08 · AUSTRALIA
For MELBOURNE BIOTECH · 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 MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection 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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/20/2020; address is 5505 35 Queens Bridge Street , Southbank, Victoria AUSTRALIA, verified against its source on 2026-09-16.
- Firm
- MELBOURNE BIOTECH 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
- 5505 35 Queens Bridge Street , Southbank, Victoria AUSTRALIA verified
- Date published
- 10/20/2020 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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test each item verified
What the source says
MELBOURNE BIOTECH Date Published : 10/20/2020 5505 35 Queens Bridge Street , Southbank, Victoria AUSTRALIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/20/2020 Desc: MB COVID-19 Antibody Rapid Detection Test 83 Q - - KO Reagent, coronavirus serological Date Published: 10/20/2020 Desc: MB COVID-19 Antibody Rapid Detection Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/20/2020 Desc: MB COVID-19 Antibody Rapid Detection Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/20/2020 Desc: MB COVID-19 Antibody Rapid Detection Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html