Identity
- Trade Name
- TruSight™ Cystic Fibrosis Library Preparation FDA UDI
- Generic Name
- Nucleic acid library construction kit IVD FDA UDI
- Device Name
- The TruSight™ Cystic Fibrosis Library Prep is a library preparation kit that supports the TruSight Cystic Fibrosis 139 Variant Assay and the TruSight Cystic Fibrosis Clinical Sequencing Assay. The TruSight Cystic Fibrosis Library Preparation is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035693, TruSight™ Cystic Fibrosis Library Prep, 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep, 3/3. FDA UDI
- Model / Reference
- 20036925 FDA UDI
- Description
- The TruSight™ Cystic Fibrosis Library Prep is a library preparation kit that supports the TruSight Cystic Fibrosis 139 Variant Assay and the TruSight Cystic Fibrosis Clinical Sequencing Assay. The TruSight Cystic Fibrosis Library Preparation is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035693, TruSight™ Cystic Fibrosis Library Prep, 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep, 3/3. FDA UDI
Identifiers
- Catalog Number
- 20036925 FDA UDI
- Primary DI / UDI-DI
- 00816270020149 FDA UDI
- FDA Product Code
- PFT FDA UDI
- GMDN Term
- Nucleic acid library construction kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
TruSight™ Cystic Fibrosis Library Preparation by Illumina, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Illumina, Inc.
Sources (1)
- FDA UDI 5234fc51-bcdc-41f4-ba5b-ca8f217e255a 36 fields · synced May 30, 2026