Identity
- Trade Name
- MEDTOXScan® QC Test Devices FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls. FDA UDI
- Model / Reference
- 833075 FDA UDI
- Description
- QC Test Devices used to detect errors associated with the MEDTOXScan® Reader and a contaminated contact imaging sensor (CIS), and to verify that the CIS cleaning procedure using the MEDTOXScan® Cleaning Cassette effectively removed any contamination. QC Test Devices are intended to function as an optical performance system check for the MEDTOXScan® Reader only, and not intended to replace the need for external controls. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00690286000070 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiplex analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Multiplex analyser IVD, laboratory
MEDTOXScan® QC Test Devices by Medtox Diagnostics, Inc. — Class I — 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® 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.
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
K091454 also covers:
- MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.
- MEDTOXScan® Cleaning Cassette — 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.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtox Diagnostics, Inc.
Sources (1)
- FDA UDI cef05c5b-a459-4cdd-9fac-77109666963c 35 fields · synced Jun 8, 2026