FDA UDI
In Commercial Distribution
🇺🇸 United States
Human IgG2 SPA PLUS Bulk Kit
DI: 05051700016384
·
Model: NK007.10S
·
THE BINDING SITE GROUP LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Human IgG2 SPA PLUS Bulk Kit
- Primary DI
- 05051700016384
- Version / Model
- NK007.10S
- 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
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- cf68c7d2-651e-4b13-ae33-c228be53a735
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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53787 | Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a nephelometry/turbidimetry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051700016384 | GS1 |
Customer Contacts
- Phone
- +4401214569500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius