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Sign in to claim this brandLumatas Biosystems, Inc.
United States·US-MF-000017316
Last updated May 24, 2026
What Lumatas Biosystems, Inc. makes
Lumatas Biosystems, Inc. develops analyte-specific reagent in vitro diagnostic (IVD) assays, including the goldFISH platform, which appears to support diagnostic testing for specific biological markers.
These products are classified as Class A or Class I devices and are registered in the EU’s EUDAMED database and the U.S. FDA’s Unique Device Identifier (UDI) system. The company 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 types of medical devices does Lumatas Biosystems, Inc. manufacture?
Lumatas Biosystems, Inc. specializes in developing analyte-specific reagent in vitro diagnostic (IVD) assays, which are designed to detect and measure specific biological markers in clinical samples. Their primary focus is on the goldFISH platform, a product line used for diagnostic testing purposes. These devices are intended for laboratory use to aid in medical diagnosis.
Where is Lumatas Biosystems, Inc. based, and how does this affect its regulatory compliance?
Lumatas Biosystems, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including registration in the FDA’s Unique Device Identifier (UDI) system. Additionally, since their products are marketed in the EU, they are also listed in EUDAMED, the European Union’s medical device registry, ensuring compliance with both U.S. and EU regulatory requirements.
Which regulatory registries list Lumatas Biosystems, Inc.’s devices, and why are these important?
Lumatas Biosystems, Inc.’s devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s UDI system (Unique Device Identifier database). These registries are critical because they ensure transparency in the medical device supply chain, facilitate traceability for regulatory authorities, and help healthcare providers verify the legitimacy and compliance status of the devices in use.
How are Lumatas Biosystems, Inc.’s devices classified under medical device regulations?
Lumatas Biosystems, Inc.’s devices are classified as Class A or Class I medical devices. This classification is typically assigned to low-risk devices, such as certain IVD assays, where the risk to patient safety is minimal. The classification determines the regulatory pathway and oversight required for market authorization, with Class A/Class I devices generally requiring less stringent pre-market review compared to higher-risk categories.
Why might a healthcare provider need to check if Lumatas Biosystems, Inc.’s devices are listed in regulatory databases?
Healthcare providers may verify whether Lumatas Biosystems, Inc.’s devices are listed in EUDAMED or the FDA’s UDI system to confirm their legitimacy, ensure compliance with regulatory standards, and confirm that the devices meet necessary safety and performance requirements. This step helps prevent the use of counterfeit or unapproved devices, reducing risks in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1870, Milmont Drive, Milpitas, United States
- Website
- lumatas.com
- —
- —
- [email protected]
- Phone
- 1-510-651-8890
- PRRC Contact
- T. Joseph Yuen
- EUDAMED SRN
- US-MF-000017316
- FDA FEI Number
- —
- DUNS Number
- 080169635
Catalogue (55)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| goldFISH | DF016 | FDA UDI | Class I | Active |
| goldFISH | DF067 | FDA UDI | Class I | Active |
| goldFISH | DF001 | FDA UDI | Class I | Active |
| goldFISH | DF129 | FDA UDI | Class I | Active |
| goldFISH | DF458 | FDA UDI | Class I | Active |
| goldFISH | DF480 | FDA UDI | Class I | Active |
| goldFISH | DF073 | FDA UDI | Class I | Active |
| goldFISH | DF282 | FDA UDI | Class I | Active |
| goldFISH | DF047 | FDA UDI | Class I | Active |
| goldFISH | DF207 | FDA UDI | Class I | Active |
| goldFISH | DF059 | FDA UDI | Class I | Active |
| goldFISH | DF046 | FDA UDI | Class I | Active |
| goldFISH | DF015 | FDA UDI | Class I | Active |
| goldFISH | DF069 | FDA UDI | Class I | Active |
| goldFISH | DF043 | FDA UDI | Class I | Active |
| goldFISH | DF035 | FDA UDI | Class I | Active |
| goldFISH | DF330 | FDA UDI | Class I | Active |
| goldFISH | DF204 | FDA UDI | Class I | Active |
| goldFISH | DF514 | FDA UDI | Class I | Active |
| goldFISH | DF091 | FDA UDI | Class I | Active |
| goldFISH | DF209 | FDA UDI | Class I | Active |
| goldFISH | DF036 | FDA UDI | Class I | Active |
| goldFISH | DF044 | FDA UDI | Class I | Active |
| goldFISH | DF027 | FDA UDI | Class I | Active |
| goldFISH | DF094 | FDA UDI | Class I | Active |
| goldFISH | DF040 | FDA UDI | Class I | Active |
| goldFISH | DF081 | FDA UDI | Class I | Active |
| goldFISH | DF008 | FDA UDI | Class I | Active |
| goldFISH | DF156 | FDA UDI | Class I | Active |
| goldFISH | DF005 | FDA UDI | Class I | Active |
| goldFISH | DF068 | FDA UDI | Class I | Active |
| goldFISH | DF101 | FDA UDI | Class I | Active |
| goldFISH | DF037 | FDA UDI | Class I | Active |
| goldFISH | DF100 | FDA UDI | Class I | Active |
| goldFISH | DF206 | FDA UDI | Class I | Active |
| goldFISH | DF045 | FDA UDI | Class I | Active |
| goldFISH | DF088 | FDA UDI | Class I | Active |
| goldFISH | DF006 | FDA UDI | Class I | Active |
| goldFISH | DF208 | FDA UDI | Class I | Active |
| goldFISH | DF103 | FDA UDI | Class I | Active |
| Antigen Retrieval Solution Neutral (50X) | R1011-125 | EUDAMEDFDA UDI | Class A | Active |
| Hematoxylin Solution | R1041-030 | EUDAMEDFDA UDI | Class A | Active |
| Lumatas Titan Autostainer | Lumatas Titan Autostainer | EUDAMEDFDA UDI | Class A | Active |
| Deparaffinization Solution | R1001-030 | EUDAMEDFDA UDI | Class A | Active |
| Titan AP Fast Red 30mL Kit | R2023-000 | EUDAMEDFDA UDI | Class A | Active |
| Titan Prime Universal HRP Polymer Detection Kit with DAB | R2010-000 | EUDAMEDFDA UDI | Class A | Active |
| Titan HRP DAB 30 mL Kit | R2013-000 | EUDAMEDFDA UDI | Class A | Active |
| Titan Prime Universal AP Polymer Detection Kit with Fast Red | R2020-000 | EUDAMEDFDA UDI | Class A | Active |
| Titan Double Stain Kit | R2030-000 | EUDAMEDFDA UDI | Class A | Active |
| DAB Away Kit | R3010-000 | EUDAMEDFDA UDI | Class A | Active |
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