FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON® XL MUREX Anti-HDV
DI: 08056771104265
·
Model: 318260
·
DIASORIN SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- LIAISON® XL MUREX Anti-HDV
- Primary DI
- 08056771104265
- Version / Model
- 318260
- Company Name
- DIASORIN SPA
- Labeler DUNS
- 630822989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 1
- Public Version Date
- 2026-01-20
- Public Version Status
- New
- Public Device Record Key
- 1bbbd30c-263b-46b4-b7da-81d58f42a99f
Device Description
LIAISON® XL MUREX Anti-HDV assay - Italy manufactured kit
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 |
|---|---|---|---|---|
| SGW | Device To Detect Antibodies To Hepatitis D Virus | Immunology | 866.3176 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48398 | Hepatitis D virus total antibody IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis D virus in a clinical specimen, using an chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056771104265 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN250032 | 000 |