FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON XL MUREX Anti-HBe
DI: 08056771103428
·
Model: 318160
·
DIASORIN SPA
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LIAISON XL MUREX Anti-HBe
- Primary DI
- 08056771103428
- Version / Model
- 318160
- Company Name
- DIASORIN SPA
- Labeler DUNS
- 630822989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-13
- Public Version
- 1
- Public Version Date
- 2021-04-21
- Public Version Status
- New
- Public Device Record Key
- 9edf36d9-082f-4193-a4c1-d3a43c0b9521
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48348 | Hepatitis B virus e-antigen 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 B virus e-antigen in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18056771103425 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08056771103428 | GS1 |