Identity
- Trade Name
- PROFILE®-V MEDTOXScan® FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine. FDA UDI
- Model / Reference
- 604028 FDA UDI
- Description
- A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00690286000056 FDA UDI
- FDA Product Code
- DIS FDA UDIDJR FDA UDIJXM FDA UDIDKZ FDA UDIDJG FDA UDIDJC FDA UDIDIO FDA UDILCM FDA UDILDJ FDA UDI
- GMDN Term
- Multiplex analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3150 FDA UDI862.3620 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3870 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, clinicalMultiplex analyser IVD, laboratory
PROFILE®-V MEDTOXScan® 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
K080635 also covers:
- MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® Cleaning Cassette — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® QC Test Devices — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® Reader — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
K091454 also covers:
- MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® Cleaning Cassette — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® QC Test Devices — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® Reader — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
K100023 also covers:
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 f556dfe1-e3de-43c5-939b-d4420f81d74c 36 fields · synced Jun 8, 2026