Identity
- Trade Name
- xTAG® CYP2D6 Kit v3 FDA UDI
- Generic Name
- Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex FDA UDI
- Device Name
- The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. FDA UDI
- Model / Reference
- I030E0443 FDA UDI
- Description
- The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. FDA UDI
Identifiers
- Catalog Number
- I030E0443 FDA UDI
- Primary DI / UDI-DI
- 00840487101025 FDA UDI
- FDA Product Code
- NTI FDA UDI
- GMDN Term
- Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3360 FDA UDI
- Commercial Distribution
- Not 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
xTAG® CYP2D6 Kit v3 by Luminex Molecular Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Luminex Molecular Diagnostics, Inc.
Sources (1)
- FDA UDI ffd30fb1-a5df-4ba1-8bc6-8a85eb57c0e3 37 fields · synced Jun 1, 2026