FEI 3004445302
Diazyme Laboratories, Inc.
12889 GREGG CT, POWAY, CA, US
MDR events4All time
Recalls0All time
Registered products39
Establishment typeManufactureManufacture Medical Device
Registered product codes
39 product codes
Recent MDR events
4 on file
- DIAZYME DZ-LITE SARS-COV-2 IGG CLIA KITApr 13, 2021Malfunction2032900-2021-00002
- DIAZYME DZ-LITE SARS-COV-2 IGM CLIA KITApr 13, 2021Malfunction2032900-2021-00003
- DIAZYME DZ-LITE SARS-COV-2 IGG CLIA KITMar 24, 2021Malfunction2032900-2021-00001
- DIAZYME LABORATORIES DIAZYME DZ-LITE SARS-COV-2 IGGJan 5, 2021MalfunctionMW5098674
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3004445302.
FDA inspections
0 on file
No inspections on file for this FEI number.
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
0 on file
No import refusals on file for this FEI number.