FEI 3008959428
Sd Biosensor, Inc.
74, Osongsaengmyeong 4-ro, Osong-eup, Cheongju-si Chungbuk, KR
MDR events195All time
Recalls2All time
Registered products7
Establishment typeManufactureManufacture Medical Device
Registered product codes
7 product codes
Recent MDR events
195 on file
- COVID-19 AT-HOME TESTJul 3, 2023Malfunction1823260-2023-02154
- COVID-19 AT-HOME TESTJun 23, 2023Malfunction1823260-2023-02077
- COVID-19 AT-HOME TESTJun 21, 2023Malfunction1823260-2023-02034
- COVID-19 AT-HOME TESTJun 2, 2023Malfunction1823260-2023-01816
- COVID-19 AT-HOME TEST PILOTMay 26, 2023MalfunctionMW5117944
- COVID-19 AT-HOME TESTMay 23, 2023Malfunction1823260-2023-01728
- PILOT COVID-19 AT-HOME TESTMay 16, 2023MalfunctionMW5117581
- PILOT COVID-19 AT-HOME TESTMay 16, 2023MalfunctionMW5117582
- PILOT COVID-19 AT-HOME TESTMay 16, 2023MalfunctionMW5117583
- PILOT COVID-19 AT-HOME TESTMay 16, 2023MalfunctionMW5117584
Recalls
2 on file
- Open, ClassifiedMay 23, 2023
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
View FDA record ↗ - Open, ClassifiedUnknown
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
View FDA record ↗
Compliance history
Matched by FEI 3008959428.
FDA inspections
2 on file
- No Action Indicated (NAI)Nov 9, 2023
Compliance: Devices
- No Action Indicated (NAI)Nov 9, 2023
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Jun 20, 2025
75NBW \ SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER