FDA UDI
In Commercial Distribution
🇺🇸 United States
NovaSeq™ 6000Dx Library Tube
DI: 00816270020552
·
Model: 20062290
·
ILLUMINA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NovaSeq™ 6000Dx Library Tube
- Primary DI
- 00816270020552
- Version / Model
- 20062290
- Catalog Number
- 20062290
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-18
- Public Version
- 1
- Public Version Date
- 2022-10-26
- Public Version Status
- New
- Public Device Record Key
- ef4ed7a2-9217-4b53-a72d-a1a8917cb7e9
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFT | Reagents For Molecular Diagnostic Test Systems | Clinical Chemistry | 862.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62172 | Laboratory waste receptacle IVD | A non-sterile container intended to collect and contain disposable materials/devices that have been contaminated due to contact with bodily fluids/substances (e.g., blood, sputum, urine, faeces) resulting from in vitro diagnostic procedures. It is typically in the form of a sack, box, or bottle made of durable plastic impervious to microorganisms. It may be used to collect solid and/or liquid waste from a laboratory instrument or analyser. This is a single-use device intended to be disposed of with its contents. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816270020552 | GS1 |
Customer Contacts
- Phone
- 800-809-4566
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius