FDA UDI
In Commercial Distribution
🇺🇸 United States
SSP DQ Low
DI: 07340035501022
·
Model: 101.201-48u
·
CareDx AB
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SSP DQ Low
- Primary DI
- 07340035501022
- Version / Model
- 101.201-48u
- Company Name
- CareDx AB
- Labeler DUNS
- 558836388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 1
- Public Version Date
- 2023-07-26
- Public Version Status
- New
- Public Device Record Key
- fa8512a1-59ad-48dc-99a9-b84e9719ff4a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56361 | HLA class II antigen tissue typing IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class II antigens in a clinical specimen, using a multiplex method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07340035501022 | GS1 |