Simplicity Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Simplicity Diagnostics, Inc. makes
Simplicity Diagnostics, Inc. manufactures serum control products for infectious disease and autoimmune testing, including controls for antistreptolysin O (ASO), syphilis, infectious mononucleosis, rheumatoid factor, and C-reactive protein assays. These products are designed to support laboratory quality assurance by providing reference standards for diagnostic testing.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. These controls are intended for use in the United States, where the manufacturer is based.
Catalogue
Tech Simple Antistreptolysin O Aso Serum Control Ref K922723
Regimes: 510(k) Registry: 510(k)Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control Ref K970100
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Tech Simple Rheumatoid Factor Serum Control Ref K922725
Regimes: 510(k) Registry: 510(k)Tech Dimple C-Reactive Protein Serum Control Ref K922722
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Simplicity Diagnostics, Inc. have in the registry?
The registry currently lists 5 devices for Simplicity Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simplicity Diagnostics, Inc.'s devices?
Among its 5 most recently registered devices, Simplicity Diagnostics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Simplicity Diagnostics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Simplicity 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 Simplicity Diagnostics, Inc. in the registry?
The most recently registered devices listed for Simplicity Diagnostics, Inc. include TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL, TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL, TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL and TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL.