Identity
- Trade Name
- MiSeqDx Universal Kit 1.0 FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/5 15039485 MiSeqDx Universal Kit 1.0 1A 15039488 MiSeqDx Universal Kit 1.0 1B 15039492 MiSeqDx Universal Kit 1.0 2/5 15039498 MiSeqDx Universal Kit 1.0 3/5 15039494 MiSeqDx Universal Kit 1.0 3A 15039496 MiSeqDx Universal Kit 1.0 3B 15039500 MiSeqDx Universal Kit 1.0 4/5 15039503 MiSeqDx Universal Kit 1.0 5/5 FDA UDI
- Model / Reference
- 15038741 FDA UDI
- Description
- The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/5 15039485 MiSeqDx Universal Kit 1.0 1A 15039488 MiSeqDx Universal Kit 1.0 1B 15039492 MiSeqDx Universal Kit 1.0 2/5 15039498 MiSeqDx Universal Kit 1.0 3/5 15039494 MiSeqDx Universal Kit 1.0 3A 15039496 MiSeqDx Universal Kit 1.0 3B 15039500 MiSeqDx Universal Kit 1.0 4/5 15039503 MiSeqDx Universal Kit 1.0 5/5 FDA UDI
Identifiers
- Catalog Number
- DX-103-1001 FDA UDI
- Primary DI / UDI-DI
- 00816270020040 FDA UDI
- 510(k) Number
- DEN130042 FDA UDI
- FDA Product Code
- PFT FDA UDI
- GMDN Term
- Nucleic acid sequencing reagent 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MiSeqDx Universal Kit 1.0 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 fddb1e32-cea9-417b-90ca-23def8d73a3c 37 fields · synced May 30, 2026