Identity
- Trade Name
- NovaSeq™ 6000Dx S2 Buffer Cartridge FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- The NovaSeq™ 6000Dx S2 Buffer Cartridge is a single-use set of buffers and wash solution prefilled in the Cartridge. The set is boxed together in one box 20046945, NovaSeq™ 6000Dx S2 Buffer Cartridge, which is labeled with the same Device Identifier. FDA UDI
- Model / Reference
- 20062292 FDA UDI
- Description
- The NovaSeq™ 6000Dx S2 Buffer Cartridge is a single-use set of buffers and wash solution prefilled in the Cartridge. The set is boxed together in one box 20046945, NovaSeq™ 6000Dx S2 Buffer Cartridge, which is labeled with the same Device Identifier. FDA UDI
Identifiers
- Catalog Number
- 20062292 FDA UDI
- Primary DI / UDI-DI
- 00816270020545 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
- 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
Category: Nucleic acid sequencing reagent kit IVD
NovaSeq™ 6000Dx S2 Buffer Cartridge by Illumina, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 75be1209-4e68-4142-ac94-514f76ca19a5 36 fields · synced May 30, 2026