Identity
- Trade Name
- xTAG® Cystic Fibrosis Mutation Detection Kit FDA UDI
- Generic Name
- Cystic fibrosis IVD, kit, multiplex FDA UDI
- Device Name
- The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens FDA UDI
- Model / Reference
- I006C0068 FDA UDI
- Description
- The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens FDA UDI
Identifiers
- Catalog Number
- I006C0068 FDA UDI
- Primary DI / UDI-DI
- 00840487100455 FDA UDI
- FDA Product Code
- NUA FDA UDI
- GMDN Term
- Cystic fibrosis IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5900 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® Cystic Fibrosis Mutation Detection Kit 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 5b25ecf7-4ee2-4a75-9151-29cd80aad865 37 fields · synced Jun 1, 2026