American Micro Scan
Country not established
- Devices
- 25
What American Micro Scan makes
American Micro Scan produces microbiological diagnostic products, including chromogenic stain kits, culture media, rapid antigen tests for bacterial infections (e.g., Group A Streptococcus and *Haemophilus influenzae* type b), and identification panels for yeast, anaerobic bacteria, and respiratory/urinary pathogens. Their portfolio also covers antimicrobial susceptibility testing panels for both Gram-negative and Gram-positive organisms, as well as fluorescent antibody tests for *Chlamydia* detection in clinical smears.
The company’s devices are regulated under FDA classifications, with most falling under Class I and Class II, and are authorised via 510(k) and PMA pathways. Products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
Catalogue
Search and filter all 25 devicesFrequently asked questions
How many devices does American Micro Scan have in the registry?
The registry currently lists 25 devices for American Micro Scan. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Micro Scan's devices?
Among its 25 most recently registered devices, American Micro Scan has devices listed in FDA 510(k) (24 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do American Micro Scan's devices fall under?
Among its 25 most recently registered devices, the classes recorded for American Micro Scan's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Micro Scan in the registry?
The most recently registered devices listed for American Micro Scan include TRICHROME STAIN, P & T MEDIUM, IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST and IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES.