Identity
- Trade Name
- NovaSeq™ 6000Dx Library Tube FDA UDI
- Generic Name
- Laboratory waste receptacle IVD FDA UDI
- Device Name
- The Illumina NovaSeq™ 6000Dx Library Tube is intended to hold sample libraries for sequencing with NovaSeq 6000Dx S2 or S4 reagent kits and validated assays. The tube is boxed in one box, 20046942, NovaSeq™ 6000Dx Library Tube, which is labeled with the same Device Identifier. FDA UDI
- Model / Reference
- 20062290 FDA UDI
- Description
- The Illumina NovaSeq™ 6000Dx Library Tube is intended to hold sample libraries for sequencing with NovaSeq 6000Dx S2 or S4 reagent kits and validated assays. The tube is boxed in one box, 20046942, NovaSeq™ 6000Dx Library Tube, which is labeled with the same Device Identifier. FDA UDI
Identifiers
- Catalog Number
- 20062290 FDA UDI
- Primary DI / UDI-DI
- 00816270020552 FDA UDI
- FDA Product Code
- PFT FDA UDI
- GMDN Term
- Laboratory waste receptacle 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: Laboratory waste receptacle IVD
NovaSeq™ 6000Dx Library Tube by Illumina, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory waste receptacle IVD.
- ELITe InGenius® Waste Box — ELITECHGROUP INC. · Class II
- Alinity m — Abbott Molecular · Class II
- Alinity m — Abbott Molecular · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Disposable Waste Container D513 REF 905-802 — Radiometer Medical ApS · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Illumina, Inc.
Sources (1)
- FDA UDI ef4ed7a2-9217-4b53-a72d-a1a8917cb7e9 36 fields · synced May 30, 2026