FDA UDI
In Commercial Distribution
🇺🇸 United States
Epstein Barr Virus LMP-1 MMab
DI: B502BSB54890
·
Model: Concentrate, 1 ml
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epstein Barr Virus LMP-1 MMab
- Primary DI
- B502BSB54890
- Version / Model
- Concentrate, 1 ml
- Catalog Number
- BSB 5489
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-16
- Public Version
- 2
- Public Version Date
- 2025-03-04
- Public Version Status
- Update
- Public Device Record Key
- 83f2486f-c908-46aa-abdd-1c9213fd0c9c
Device Description
EBV antibody is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in bufferpH 7.5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62754 | Esptein-Barr virus (EBV) antigen IVD, antibody | One or multiple immunoglobulins with the capability of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from Epstein-Barr virus (EBV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB54890 | HIBCC |