FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON® Biotrin Control Parvovirus B19 IgG Plus
DI: 08056771104036
·
Model: 311551
·
DIASORIN SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LIAISON® Biotrin Control Parvovirus B19 IgG Plus
- Primary DI
- 08056771104036
- Version / Model
- 311551
- Company Name
- DIASORIN SPA
- Labeler DUNS
- 630822989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 1
- Public Version Date
- 2024-04-16
- Public Version Status
- New
- Public Device Record Key
- 43f06767-2d03-49e4-82e0-0838987fa52e
Device Description
Italy manufactured kit.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| MYL | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50162 | Parvovirus B19 immunoglobulin G (IgG) antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Parvovirus B19 in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056771104036 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220034 | 000 |