FDA UDI
In Commercial Distribution
🇺🇸 United States
QIAcuityDx® Nanoplate 26k 24-well
DI: 04053228049685
·
Model: 1
·
QIAGEN GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QIAcuityDx® Nanoplate 26k 24-well
- Primary DI
- 04053228049685
- Version / Model
- 1
- Catalog Number
- 260001
- Company Name
- QIAGEN GmbH
- Labeler DUNS
- 317103745
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-30
- Public Version
- 1
- Public Version Date
- 2024-10-08
- Public Version Status
- New
- Public Device Record Key
- 53f08fa2-aedd-4767-b4eb-67babbba6e5f
Device Description
The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic plate-based technology to enable the QIAcuityDx® Four to be used as intended. The QIAcuity® Nanoplate 26k 24-well is used in conjunction with the QIAcuity® Nanoplate Seals, QIAcuity® Nanoplate Tray, and the QIAcuity® Roller to establish a closure to allow air displacement to push samples into the partitioning area of the QIAcuity® Nanoplate 26k 24-well during priming. The QIAcuity® Nanoplate 26k 24-well is intended for in vitro diagnostic use. The QIAcuityDx Nanoplate is not an automated device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| PHG | Droplet Digital Pcr System | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61296 | Microplate IVD | A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053228049685 | GS1 |
Customer Contacts
- Phone
- 8003627737
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius