Identity
- Trade Name
- xTAG® CYP2C19 Kit v3 FDA UDI
- Generic Name
- Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex FDA UDI
- Device Name
- The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. FDA UDI
- Model / Reference
- I046B0427 FDA UDI
- Description
- The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. FDA UDI
Identifiers
- Catalog Number
- I046B0427 FDA UDI
- Primary DI / UDI-DI
- 00840487100172 FDA UDI
- 510(k) Number
- K131565 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
- 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: Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
xTAG® CYP2C19 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 |
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Manufacturer
- Manufacturer
- Luminex Molecular Diagnostics, Inc.
Sources (1)
- FDA UDI 1e707d5b-5d67-4ce3-8bc6-b16c152d3823 37 fields · synced May 30, 2026