Spectral Diagnostics, Inc.
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- Devices
- 12
What Spectral Diagnostics, Inc. makes
Spectral Diagnostics, Inc. manufactures in vitro diagnostic tests for cardiac biomarkers, including combined assays for CK-MB, myoglobin, and troponin I, as well as standalone troponin I and myoglobin quantification tests. Their portfolio also includes rapid diagnostic tests for cardiac markers like CK-MB and assays for infectious disease detection, such as West Nile virus IgM status testing. Additional products cover endotoxin activity assays and control reagents for cardiac biomarker testing.
The company’s diagnostic devices are classified under FDA’s Class I and Class II categories, with most products authorised via the 510(k) pathway. These tests are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance for use in the United States. The manufacturer operates from the US.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Spectral Diagnostics, Inc. have in the registry?
The registry currently lists 12 devices for Spectral Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectral Diagnostics, Inc.'s devices?
Among its 12 most recently registered devices, Spectral Diagnostics, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Spectral Diagnostics, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Spectral Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectral Diagnostics, Inc. in the registry?
The most recently registered devices listed for Spectral Diagnostics, Inc. include SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST, CARDIOQUANT TROPONIN I TEST, SPECTRAL WEST NILE VIRUS IGM STATUS TEST and SPECTRAL'S 2 IN 1 (TNI-MYO).