Alfa Wassermann Diagnostic Technologies, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 26
What Alfa Wassermann Diagnostic Technologies, Inc. makes
Alfa Wassermann Diagnostic Technologies, Inc. manufactures clinical chemistry reagents and analyzers for laboratory testing, including the S40 Clinical Analyzer for assays like albumin, urea nitrogen, glucose, bilirubin, and C-reactive protein. Their portfolio also includes specialized reagents for cholesterol (HDL-C, LDL-C, triglycerides), hemoglobin A1c, creatinine, phosphorus, calcium, and magnesium measurements, as well as urine standards and systems like the ACE Axcel Clinical Chemistry System.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Their analyzers and reagents are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 26 devicesFrequently asked questions
How many devices does Alfa Wassermann Diagnostic Technologies, Inc. have in the registry?
The registry currently lists 26 devices for Alfa Wassermann Diagnostic Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alfa Wassermann Diagnostic Technologies, Inc.'s devices?
Among its 26 most recently registered devices, Alfa Wassermann Diagnostic Technologies, Inc. has devices listed in FDA 510(k) (26 devices).
What risk classes do Alfa Wassermann Diagnostic Technologies, Inc.'s devices fall under?
Among its 26 most recently registered devices, the classes recorded for Alfa Wassermann Diagnostic Technologies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alfa Wassermann Diagnostic Technologies, Inc. in the registry?
The most recently registered devices listed for Alfa Wassermann Diagnostic Technologies, Inc. include S40 CLINICAL ANALYZER, S TEST ALB, S40 CLINICAL ANALYZER, S TEST IP, S TEST UA, ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT and ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT.