FDA UDI
In Commercial Distribution
🇺🇸 United States
FLC Control Level 2
DI: 03607360051139
·
Model: 5113
·
SEBIA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FLC Control Level 2
- Primary DI
- 03607360051139
- Version / Model
- 5113
- Catalog Number
- 5113
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-31
- Public Version
- 1
- Public Version Date
- 2023-04-10
- Public Version Status
- New
- Public Device Record Key
- 746ac0cf-137e-438e-9f5b-3589be31a54f
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
- Yes
- 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 |
|---|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | Immunology | 866.5550 | 2 |
| DEH | Lambda, Antigen, Antiserum, Control | Immunology | 866.5550 | 2 |
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 | 03607360051139 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius