FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BP 230 ELISA TEST
DI: B110RGM7613D0
·
Model: RG-M7613-D
·
Bion Enterprises, Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BP 230 ELISA TEST
- Primary DI
- B110RGM7613D0
- Version / Model
- RG-M7613-D
- Catalog Number
- RG-M7613-D
- Company Name
- Bion Enterprises, Ltd.
- Labeler DUNS
- 024824641
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2020-06-18
- Public Version Status
- Update
- Public Device Record Key
- 8f8eb0db-2f32-4bcb-9f5a-a0eb52b8415b
- Distribution End Date
- 2020-05-26
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62295 | Bullous pemphigoid antigen 1 (BPAG1) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to bullous pemphigoid antigen 1 (BPAG1), also known as BP230, in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune skin disease bullous pemphigoid. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B110RGM7613D0 | HIBCC |
Customer Contacts
- Phone
- 847-544-5044
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071961 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius