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Sign in to claim this brandIDUN SOLUTIONS LLC
US
Last updated May 24, 2026
What IDUN SOLUTIONS LLC makes
IDUN Solutions LLC manufactures in vitro diagnostic (IVD) kits and rapid immunochromatographic test (ICT) devices designed for clinical use. These products detect cocaine, cannabinoids, morphine, amphetamines, methamphetamine, phencyclidine (PCP), benzodiazepines, and barbiturates in biological samples, including cocaine and metabolite tests. The portfolio includes both single-drug and multi-drug testing formats, such as the PreKnow and PreChek series, as well as a multi-drug test square cup.
The company’s diagnostic devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in clinical settings to support rapid drug detection and are regulated under U.S. medical device laws.
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 IDUN Solutions LLC manufacture?
IDUN Solutions LLC specializes in in vitro diagnostic (IVD) devices, including rapid immunochromatographic test (ICT) kits and clinical testing formats. Their products detect substances such as cocaine, cannabinoids, morphine, amphetamines, methamphetamine, phencyclidine (PCP), benzodiazepines, and barbiturates in biological samples. These devices are designed for clinical use to provide rapid results, supporting drug detection in healthcare settings.
Where is IDUN Solutions LLC based?
IDUN Solutions LLC is based in the United States. The company’s headquarters and operations are located within the country, aligning with U.S. regulatory standards for medical devices.
Which regulatory registries or databases list IDUN Solutions LLC’s devices?
IDUN Solutions LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of their medical devices under U.S. regulatory oversight, particularly for in vitro diagnostics like their PreKnow and PreChek series.
How are IDUN Solutions LLC’s devices classified under FDA regulations?
IDUN Solutions LLC’s devices fall under three FDA classification categories: Class I, Class II, and Unclassified (U). Class I devices generally pose the lowest risk, while Class II devices require special controls to ensure safety and effectiveness. The Unclassified (U) designation indicates devices that do not fit neatly into the standard risk-based classification system but are still subject to regulatory oversight. These classifications help determine the regulatory pathway for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080651010
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PreKnow | 21100015410308 | FDA UDI | Class II | Active |
| PreKnow | 21103015410508 | FDA UDI | Class I | Active |
| PreChek | 21512050010308 | FDA UDI | Class II | Active |
| N/M | 12511315000034 | FDA UDI | Class II | Active |
| PreKnow | 21505040010308-C | FDA UDI | U | Active |
| PreKnow | 21115061010308-B | FDA UDI | Class II | Active |
| PreKnow | 21505040010308 | FDA UDI | Class II | Active |
| Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) | IDTH-115-15P | FDA UDI | Class II | Unknown |
| PreKnow | 21115061010308 | FDA UDI | Class II | Active |
| PreChek Multi-Drug Test Square Cup | IDOA-7325SC-25P | FDA UDI | Class II | Active |
| Wholepower | 41511104001034 | FDA UDI | U | Active |
| N/M | 12511105000034 | FDA UDI | Class II | Active |
| PreChek | 21512050010308-A | FDA UDI | Class II | Active |
| PreKnow | IDOA-756 | FDA UDI | U | Unknown |
| PreKnow | IDOA-3105 | FDA UDI | Class II | Unknown |
| PreKnow | 21100015410508 | FDA UDI | Class II | Active |
| Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards) | IDOA-755-5P | FDA UDI | Class II | Unknown |
| PreKnow Pregnancy Test (25 hCG Strips) | ID1-S-25P | FDA UDI | Class II | Active |
| PreChek Multi-Drug Test Cup | IDOA-7225RC-5P | FDA UDI | Class II | Unknown |
| PreKnow | 21114061610308 | FDA UDI | Class II | Active |
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