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NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 20028870
Identity
- Trade Name
- NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- NextSeq™ 550Dx High Output Reagent Kit EUDAMEDThe NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles. FDA UDI
- Model / Reference
- 20028870 EUDAMEDFDA UDI
- Description
- The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles. FDA UDI
Identifiers
- Catalog Number
- 20028870 FDA UDI
- Primary DI / UDI-DI
- 00816270020132 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081627002HOKTQU EUDAMED
- FDA Product Code
- PFT FDA UDI
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid sequencing reagent kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) by Illumina, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0081627002HOKTQU | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Illumina, Inc.
- EUDAMED SRN
- US-MF-000013476
- Authorised Representative
- Illumina Netherlands B.V. NL-AR-000012614
Sources (2)
- EUDAMED e8ebdd1a-2c54-4d4b-acab-bc4106d5876c 61 fields · synced Jun 18, 2026
- FDA UDI cd57fb4b-787d-479b-924c-e48450391f47 35 fields · synced May 30, 2026