FDA UDI
In Commercial Distribution
🇺🇸 United States
Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™
DI: 05051700018715
·
Model: NQ018.IM
·
THE BINDING SITE GROUP LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™
- Primary DI
- 05051700018715
- Version / Model
- NQ018.IM
- 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
- 2017-06-05
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 004202a5-35a0-4218-8aeb-a59ac2118fdd
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 |
|---|---|---|---|---|
| 41431 | Kappa/lambda light chain immunoglobulin IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051700018715 | GS1 |
Customer Contacts
- Phone
- +4401214569500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius