Dade Microscan, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 40
What Dade Microscan, Inc. makes
Dade Microscan, Inc. manufactures dried antimicrobial susceptibility testing panels for microbiology laboratories. These include gram-positive and gram-negative panels for identifying bacterial resistance, such as MIC/COMBO panels with ertapenem, ESBL screening, and various antimicrobial agents like erythromycin, tetracycline, and cefotaxime. The portfolio also covers dedicated panels for *Streptococcus* species testing, including MICROSTREP PLUS variants with additional antimicrobial agents.
The company’s products are regulated under FDA’s Class I and Class II device classifications and are listed via the 510(k) pathway. These panels are intended for in vitro diagnostic use in clinical microbiology settings. The manufacturer is based in the United States.
Catalogue
Search and filter all 40 devicesFrequently asked questions
How many devices does Dade Microscan, Inc. have in the registry?
The registry currently lists 40 devices for Dade Microscan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dade Microscan, Inc.'s devices?
Among its 40 most recently registered devices, Dade Microscan, Inc. has devices listed in FDA 510(k) (40 devices).
What risk classes do Dade Microscan, Inc.'s devices fall under?
Among its 40 most recently registered devices, the classes recorded for Dade Microscan, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dade Microscan, Inc. in the registry?
The most recently registered devices listed for Dade Microscan, Inc. include MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM, MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS, ESBL SCREEN, STREPTOCOCCUS MIC PANEL and MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN.