Medical Laboratory Automation Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 17
What Medical Laboratory Automation Systems, Inc. makes
The company manufactures laboratory automation devices, including reagent dispensers for diagnostic testing and a range of automatic coagulation timers and analyzers for blood clotting studies. It also produces diagnostic reagents for detecting *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and viral pathogens via nucleic acid amplification tests.
These devices are regulated under FDA 510(k) clearance, with most classified as Class II (e.g., coagulation analyzers and diagnostic reagents) and some as Class I (e.g., reagent dispensers). The portfolio is listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Medical Laboratory Automation Systems, Inc. have in the registry?
The registry currently lists 17 devices for Medical Laboratory Automation Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Laboratory Automation Systems, Inc.'s devices?
Among its 17 most recently registered devices, Medical Laboratory Automation Systems, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Medical Laboratory Automation Systems, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Medical Laboratory Automation 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 Medical Laboratory Automation Systems, Inc. in the registry?
The most recently registered devices listed for Medical Laboratory Automation Systems, Inc. include TYTEM(R) REAGENT DISPENSER, ELECTRA 900C AUTOMATIC COAGULATION TIMER, CHLAMYDIA ACCU-CULSHURE TM and MLA ELECTRA 750 COAGULATION TIMER.