Identity
- Trade Name
- EZ-SCREEN® CUP FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A qualitative one-step immunochromatographic test panel for the detection of Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine. FDA UDI
- Model / Reference
- 605211 FDA UDI
- Description
- A qualitative one-step immunochromatographic test panel for the detection of Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00690286000698 FDA UDI
- FDA Product Code
- DKZ FDA UDIDJG FDA UDIDIO FDA UDILCM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3650 FDA UDI862.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, rapid ICT, clinical
Ez-Screen® Cup by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K982211 also covers:
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
K992111 also covers:
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-II — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-IIA — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-IIA — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-IIA — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-IIA — MEDTOX DIAGNOSTICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtox Diagnostics, Inc.
Sources (1)
- FDA UDI a520e47a-871b-445b-a39a-eb638d6d7b5a 36 fields · synced Jun 8, 2026