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Evidence MultiSTAT DOA Urine MultiPlex
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K030360
Identity
- Trade Name
- Evidence MultiSTAT DOA Urine MultiPlex FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, multiplex FDA UDI
- Device Name
- The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs. FDA UDI
- Model / Reference
- EV4393 FDA UDI
- Description
- The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs. FDA UDI
Identifiers
- Catalog Number
- EV4393 FDA UDI
- Primary DI / UDI-DI
- 05055273216752 FDA UDI
- 510(k) Number
- K221550 FDA UDI
- FDA Product Code
- DIS FDA UDIDJG FDA UDILCM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3150 FDA UDI862.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, kit, multiplex
Evidence MultiSTAT DOA Urine MultiPlex by Randox Laboratories, Ltd. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Multiple drugs of abuse IVD, kit, multiplex.
- DOA — Randox Laboratories, Ltd. · U
- DOA — Randox Laboratories, Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030360 | Class II | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI 5105e85f-03a5-4989-8483-8dc17df01e9c 61 fields · synced Jun 18, 2026
- FDA 510(k) K030360 1 fields · synced Jun 5, 2026