FDA UDI
In Commercial Distribution
🇺🇸 United States
Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System
DI: B110EB50120
·
Model: EB-5012
·
Bion Enterprises, Ltd.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System
- Primary DI
- B110EB50120
- Version / Model
- EB-5012
- Catalog Number
- EB-5012
- Company Name
- Bion Enterprises, Ltd.
- Labeler DUNS
- 024824641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2020-03-04
- Public Version Status
- Update
- Public Device Record Key
- 60d56b77-07be-4309-a58d-426977bbdef8
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 |
|---|---|---|---|---|
| LJN | Antibody Igm, If, Epstein-Barr Virus | Microbiology | 866.3235 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49661 | Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen. | No | Active |
| 49667 | Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to 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 | B110EB50120 | HIBCC |
Customer Contacts
- Phone
- 847-544-5044
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K893240 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 8 Degrees Celsius