FDA UDI
In Commercial Distribution
🇺🇸 United States
Mumps IgG Control
DI: B110MUG80200
·
Model: MUG-8020
·
Bion Enterprises, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mumps IgG Control
- Primary DI
- B110MUG80200
- Version / Model
- MUG-8020
- Catalog Number
- MUG-8020
- 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
- 4
- Public Version Date
- 2020-03-04
- Public Version Status
- Update
- Public Device Record Key
- fc4ad45b-673f-4cb2-87df-2487d204046b
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 |
|---|---|---|---|---|
| GRA | Antiserum, Fluorescent, Mumps Virus | Microbiology | 866.3380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49336 | Mumps virus 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 Mumps virus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B110MUG80200 | HIBCC |
Customer Contacts
- Phone
- 847-544-5044
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894624 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius