FDA UDI
In Commercial Distribution
🇺🇸 United States
Hevylite Human IgA Lambda SPA Kit
DI: 05051700017992
·
Model: NK624.S.A
·
THE BINDING SITE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hevylite Human IgA Lambda SPA Kit
- Primary DI
- 05051700017992
- Version / Model
- NK624.S.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
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7010d77e-2344-45ab-a825-20c7fec15086
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 |
|---|---|---|---|---|
| OPY | Igal Heavy & Light Chain Combined | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53758 | Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) 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 | 05051700017992 | GS1 |
Customer Contacts
- Phone
- +4401214569500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151759 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius