Bacterioscan, Inc.
US Last updated 30 May 2026
- Devices
- 6
- Registries
- GUDIDFDA 510(k)
- FDA recalls
- 0
Catalogue
BacterioScan 216Dx System Clear Cartridge - 4 Well Ref Clear Cartridge - 4 Well
BacterioScan 216Dx System Clear Cartridge - 4 Well Case Ref Clear Cartridge - 4 Well Case
BacterioScan 216Dx System Clear Cartridge - 4 Well Tray Ref Clear Cartridge - 4 Well Tray
BacterioScan 216Dx System Appliance 216DxA4 Ref Appliance 216DxA4
BacterioScan 216Dx System Ref 216Dx
BacterioScan 216Dx System Ref K172412
What Bacterioscan, Inc. makes
Bacterioscan, Inc. manufactures microbial incubator and imaging systems designed for in vitro diagnostic (IVD) use, specifically the BacterioScan 216Dx System. These systems automate microbial growth monitoring and imaging to support laboratory workflows in identifying and analyzing bacterial cultures.
The company’s portfolio is regulated under FDA Class I devices, with records submitted via 510(k) premarket notifications and included in the FDA’s Unique Device Identifier (UDI) database. The systems are listed in the US regulatory system.
Frequently asked questions
What types of medical devices does Bacterioscan, Inc. manufacture?
Bacterioscan, Inc. specializes in microbial incubator and imaging systems classified as in vitro diagnostic (IVD) devices. Their primary product, the BacterioScan 216Dx System, automates microbial growth monitoring and imaging to assist laboratories in analyzing bacterial cultures. These devices streamline workflows by providing automated detection and analysis of microbial samples.
Where is Bacterioscan, Inc. based?
Bacterioscan, Inc. is headquartered in the United States. The company’s regulatory filings and device listings reflect its operations within the US market.
Which regulatory registries or databases list Bacterioscan’s devices?
Bacterioscan’s devices are included in the FDA’s Unique Device Identifier (UDI) database and have undergone premarket review through 510(k) notifications. These records confirm their regulatory status in the US system.
How are Bacterioscan’s devices classified under FDA regulations?
Bacterioscan’s devices, such as the BacterioScan 216Dx System, fall under FDA Class I classification. This classification is typically assigned to devices posing minimal risk to users, though compliance with regulatory requirements—including 510(k) submissions—remains mandatory for market authorization.
Information
- Country
- US
- DUNS number
- 029599160