Seracare Technology
Country not established
- Devices
- 5
What Seracare Technology makes
Seracare Technology manufactures laboratory controls for urine drug screening and immunoassay testing, including controls for tumor and cardiac marker assays. These products are designed to validate the performance of diagnostic tests in clinical settings, ensuring accuracy and reliability across different assay levels.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the 510(k) premarket notification registry. The devices are intended for use in the United States, adhering to regulatory requirements for laboratory controls.
Catalogue
Urine Drug Screening Control Ref K992395
Regimes: 510(k) Registry: 510(k)Qualitrol Immunology Control, Level 1, 2 And 3 Ref K992770
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Qualitrol Tumor Marker Control, Levels 1 And 2 Ref K993631
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Seracare Technology have in the registry?
The registry currently lists 5 devices for Seracare Technology. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seracare Technology's devices?
Among its 5 most recently registered devices, Seracare Technology has devices listed in FDA 510(k) (5 devices).
What risk classes do Seracare Technology's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Seracare Technology's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Seracare Technology in the registry?
The most recently registered devices listed for Seracare Technology include URINE DRUG SCREENING CONTROL, QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3, QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2 AND 3 and QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2.