Em Diagnostic Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 288
What Em Diagnostic Systems, Inc. makes
Em Diagnostic Systems, Inc. manufactures diagnostic test kits and reagents for clinical chemistry, including assays for alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, amylase, glucose, uric acid, and phenobarbital. Their portfolio also includes calibrators and control materials, such as the Auto Trol™ Control and EMDS calibrators, designed for laboratory use in measuring blood chemistry parameters.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Em Diagnostic Systems, Inc. is based in the United States.
Catalogue
Search and filter all 288 devicesShowing 1-50 of 288
Frequently asked questions
How many devices does Em Diagnostic Systems, Inc. have in the registry?
The registry currently lists 288 devices for Em Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Em Diagnostic Systems, Inc.'s devices?
Among its 50 most recently registered devices, Em Diagnostic Systems, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Em Diagnostic Systems, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Em Diagnostic Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Em Diagnostic Systems, Inc. in the registry?
The most recently registered devices listed for Em Diagnostic Systems, Inc. include ALANINE AMINOTRANSFERASE TEST, EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95, OLYMPUS(TM) TOTAL BILIRUBIN and SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO.