FDA UDI
In Commercial Distribution
🇺🇸 United States
Immunoglobulin Isotypes (GAM) for the EXENT Analyser
DI: 05051700021050
·
Model: MSR801.M.A
·
THE BINDING SITE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Immunoglobulin Isotypes (GAM) for the EXENT Analyser
- Primary DI
- 05051700021050
- Version / Model
- MSR801.M.A
- Company Name
- THE BINDING SITE GROUP LIMITED
- Labeler DUNS
- 347045614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-27
- Public Version
- 1
- Public Version Date
- 2025-12-05
- Public Version Status
- New
- Public Device Record Key
- 8fb7660f-9931-42af-a6f8-244eee12d35b
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 |
|---|---|---|---|---|
| SGG | Mass Spectrometric, Immunoglobulins (G, A, M, D, E) | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66854 | Multiple monoclonal immunoglobulin isotype IVD, kit, mass spectrometric immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple monoclonal immunoglobulin isotypes including IgA, IgG, IgM, and may also include kappa and lambda light chains, in a clinical specimen, using a mass spectrometric immunoassay method. It is typically used to aid in the diagnosis and monitoring of monoclonal gammopathies such as multiple myeloma, Waldenström's disease, and macroglobulinaemia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051700021050 | GS1 |
Customer Contacts
- Phone
- +441214569500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250159 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius