Spectrum Diagnostic, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Spectrum Diagnostic, Inc. makes
Spectrum Diagnostic, Inc. manufactures rapid diagnostic tests for sexually transmitted infections, including transette devices for detecting gonorrhea and herpes. These products are designed for point-of-care testing, providing results in a clinical setting to support immediate patient management.
The company’s portfolio is classified under FDA’s Class I medical devices, with products listed via the 510(k) pathway. These devices are regulated under the US Food and Drug Administration’s jurisdiction, ensuring compliance with federal requirements for diagnostic testing accuracy and safety.
Catalogue
Gonorrhea Transette 3 Ref K822886
Regimes: 510(k) Registry: 510(k)Herpes Transette Ref K823443
Regimes: 510(k) Registry: 510(k)Gonorrhea Transette 1 & 3 Ref K831579
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spectrum Diagnostic, Inc. have in the registry?
The registry currently lists 3 devices for Spectrum Diagnostic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectrum Diagnostic, Inc.'s devices?
Among its 3 most recently registered devices, Spectrum Diagnostic, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Spectrum Diagnostic, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Spectrum Diagnostic, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Spectrum Diagnostic, Inc. in the registry?
The most recently registered devices listed for Spectrum Diagnostic, Inc. include GONORRHEA TRANSETTE 3, HERPES TRANSETTE and GONORRHEA TRANSETTE 1 & 3.