FDA UDI
In Commercial Distribution
🇺🇸 United States
Cellpro
DI: 26974573531033
·
Model: 802021E01-233
·
Suzhou CellPro Biotechnology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Cellpro
- Primary DI
- 26974573531033
- Version / Model
- 802021E01-233
- Company Name
- Suzhou CellPro Biotechnology Co., Ltd.
- Labeler DUNS
- 554551042
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- a9f09afe-35aa-4c32-82c9-24a63a6d9f5d
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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61305 | Assay adhesive sealing/fixation film IVD | A thin adhesive film intended to be used during in vitro diagnostic assays typically to seal the top of a microplate to prevent sample carryover and/or evaporation, and/or to fix test strips to a surface/chart to facilitate analysis. It is typically made of aluminium foil or plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 16974573531036 | GS1 | ||||
| Primary | 26974573531033 | GS1 |