FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON MeMed BV Control Set
DI: 08056771602976
·
Model: 318471
·
Diasorin Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIAISON MeMed BV Control Set
- Primary DI
- 08056771602976
- Version / Model
- 318471
- Company Name
- Diasorin Inc.
- Labeler DUNS
- 033429783
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-10
- Public Version
- 1
- Public Version Date
- 2022-08-18
- Public Version Status
- New
- Public Device Record Key
- 3dde84b2-f9a6-40c1-9773-121bf01523bb
Device Description
The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | Microbiology | 866.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65779 | Multiple cell-mediated host immune response marker IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen. It is typically used to aid in the differentiation of bacterial and viral infection, and/or to predict patient outcomes by grading disease severity. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056771602976 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213936 | 000 |