Wiener Laboratories Saic
ArgentinaFDA applicant, unverified
- Devices
- 24
What Wiener Laboratories Saic makes
Wiener Laboratories Saic manufactures diagnostic reagents for clinical chemistry assays, including enzymatic and colorimetric test kits for measuring substances like amylase, creatinine, creatine kinase (CK-NAC), cholinesterase, uric acid, bilirubin, calcium, and transferrin. Their portfolio also includes specialized reagents such as ELISA-based assays (e.g., ChagasTest) and calibrators for laboratory use.
These products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. They are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Wiener Laboratories Saic have in the registry?
The registry currently lists 24 devices for Wiener Laboratories Saic. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wiener Laboratories Saic's devices?
Among its 24 most recently registered devices, Wiener Laboratories Saic has devices listed in EUDAMED (1 device) and FDA 510(k) (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wiener Laboratories Saic's devices fall under?
Among its 24 most recently registered devices, the classes recorded for Wiener Laboratories Saic's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wiener Laboratories Saic in the registry?
The most recently registered devices listed for Wiener Laboratories Saic include WIENER LAB AMILASA 405 AA LIQUIDA, WIENER LAB. CREATININA CINETICA AA, WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA and WIENER LAB COLINESTERASA AA.