FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON MeMed BV
DI: 08056771602969
·
Model: 318470
·
Diasorin Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIAISON MeMed BV
- Primary DI
- 08056771602969
- Version / Model
- 318470
- 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
- a54ff23f-dcea-48f3-bba4-b75a28be2c52
Device Description
The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples.
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 |
|---|---|---|---|---|
| QPS | Immunoassay For Host Biomarkers Of Infection | Microbiology | 866.3215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65778 | Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid | A collection of reagents and other associated materials 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 within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. It is typically used to differentiate bacterial from viral infection, and/or to predict patient outcomes by grading disease severity. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056771602969 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213936 | 000 |