Pearl Diagnostics, Inc.
Country not established FDA establishment FEI 3022929618
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
MycoMEIA Aspergillus Assay Ref K243496
510(k) 510(k)
Company details
- FDA FEI number
- 3022929618
- Address
- 1812 Ashland Ave Ste G100, Baltimore, MD, 21205
Frequently asked questions
How many devices does PEARL DIAGNOSTICS, INC. have in the registry?
The registry currently lists 5 devices for PEARL DIAGNOSTICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list PEARL DIAGNOSTICS, INC.'s devices?
Among its 5 most recently registered devices, PEARL DIAGNOSTICS, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PEARL DIAGNOSTICS, INC.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for PEARL DIAGNOSTICS, INC.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from PEARL DIAGNOSTICS, INC. in the registry?
The most recently registered devices listed for PEARL DIAGNOSTICS, INC. include MycoMEIA Aspergillus Assay 25100, MycoMEIA Aspergillus Assay Sample Processing Columns 25102, MycoMEIA Aspergillus Assay 25X Concentrated Wash Solution 25101 and MycoMEIA Aspergillus Assay Uncoated Plates 25101.