Micronics, Inc.
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Micronics, Inc. is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 15 Nov 2026.
- Devices
- 2
Registry facts
- Registries
- FDA 510(k) 1
- FDA GUDID 1
- Device classes
- FDA Class II 2
- Identifiers
- DUNS 799245519
What Micronics, Inc. makes
Micronics, Inc. manufactures in vitro diagnostic (IVD) devices for blood grouping and pathogen detection, including agglutination-based kits for ABO/Rh typing and tests for Shiga toxin-producing *Escherichia coli* (STEC). Their products are designed for laboratory use to identify blood types and specific bacterial pathogens in clinical samples.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) and Unique Device Identifier (UDI) programs.
Catalogue
- Regimes: 510(k) Registry: GUDID
PanNAT STEC Test Ref K173330
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 799245519
- Phone
- 1-855-895-9197
Frequently asked questions
How many devices does Micronics, Inc. have in the registry?
The registry currently lists 2 devices for Micronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micronics, Inc.'s devices?
Among its 2 most recently registered devices, Micronics, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Micronics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Micronics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Micronics, Inc. in the registry?
The most recently registered devices listed for Micronics, Inc. include ABORhCard BT-101-025 and PanNAT STEC Test.