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Sign in to claim this brandIcubate, Inc.
US
Last updated May 30, 2026
What Icubate, Inc. makes
Icubate, Inc. manufactures in vitro diagnostic devices including thermal cycler nucleic acid amplification analyzers and multiple bloodstream pathogen nucleic acid test kits using nucleic acid amplification/mass spectrometry techniques. Their specific products include the iC-Reader, iC-Processor, iC-GN Assay, iC-GPC Assay, and related cassettes designed for use with the iC-System.
The company's portfolio consists of Class II medical devices listed in the FDA 510(k) database and FDA Unique Device Identification (UDI) system. Icubate, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Icubate, Inc. manufacture?
Icubate, Inc. manufactures in vitro diagnostic devices including thermal cycler nucleic acid amplification analyzers and multiple bloodstream pathogen nucleic acid test kits using nucleic acid amplification/mass spectrometry techniques.
Where is Icubate, Inc. based?
Icubate, Inc. is based in the United States, as indicated in the device data provided.
Which regulatory registries list Icubate's devices?
Icubate's devices are listed in the FDA 510(k) database and the FDA Unique Device Identification (UDI) system, as specified in the device data.
How are Icubate's devices classified?
Icubate's devices are classified as Class II medical devices, which means they are subject to special controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- icubate.com
- —
- —
- [email protected]
- Phone
- 855-256-3330
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 830140377
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iC-Reader | iCR-ADAA00000 | FDA UDI | Class II | Active |
| iC-Processor | iCP-ADAAA0000 | FDA UDI | Class II | Active |
| iC-GN Assay | iCC-AAQA00000 | FDA UDI | Class II | Active |
| iC-GPC Assay | iCC-AAJA00000 | FDA UDI | Class II | Active |
| iC-GPC Assay TM for use on the iC-SystemTM | K163390 | FDA 510(k) | Class II | Active |
| iC-GN iC-Cassette for use on the iC-System | K190341 | FDA 510(k) | Class II | Active |
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