Identity
- Trade Name
- NextSeq550Dx Reagent Kit v2(300 cyc) IVD FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the NextSeq 550Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20019558, NextSeq™ 550Dx Accessory Box – 300 cycles; 20019557, NextSeq™ 550Dx High Output Flow Cell Cartridge v2, 300 cycles; 20019555, NextSeq™ 550Dx, High Output Reagent Cartridge v2, 300 cycles; 20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles. FDA UDI
- Model / Reference
- 20019554 FDA UDI
- Description
- The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the NextSeq 550Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20019558, NextSeq™ 550Dx Accessory Box – 300 cycles; 20019557, NextSeq™ 550Dx High Output Flow Cell Cartridge v2, 300 cycles; 20019555, NextSeq™ 550Dx, High Output Reagent Cartridge v2, 300 cycles; 20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles. FDA UDI
Identifiers
- Catalog Number
- 20019554 FDA UDI
- Primary DI / UDI-DI
- 00816270020095 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
NextSeq550Dx Reagent Kit v2(300 cyc) IVD 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 0c162c60-2ff1-4a56-ad37-1f83a3f3e165 36 fields · synced May 29, 2026