FDA UDI
In Commercial Distribution
🇺🇸 United States
CAPI 3 IMMUNOTYPING
DI: 03607360026007
·
Model: 2600
·
SEBIA
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAPI 3 IMMUNOTYPING
- Primary DI
- 03607360026007
- Version / Model
- 2600
- Catalog Number
- 2600
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 859e33e9-3132-432e-8238-2a042764833f
Device Description
Device designed for the qualitative detection and the characterization of monoclonal proteins by capillary electrophoresis
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
- Yes
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | Immunology | 866.5550 | 2 |
| DEH | Lambda, Antigen, Antiserum, Control | Immunology | 866.5550 | 2 |
| CEF | Electrophoretic, Protein Fractionation | Clinical Chemistry | 862.1630 | 1 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53595 | Multiple clinical chemistry protein IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607360026007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161928 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius