FDA UDI
In Commercial Distribution
🇺🇸 United States
Seraclone Anti-k (KEL2)
DI: 07611969962464
·
Model: 808126100
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Seraclone Anti-k (KEL2)
- Primary DI
- 07611969962464
- Version / Model
- 808126100
- Catalog Number
- 808126100
- Company Name
- Bio-Rad Medical Diagnostics GmbH
- Labeler DUNS
- 312576506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-15
- Public Version
- 1
- Public Version Date
- 2019-02-15
- Public Version Status
- New
- Public Device Record Key
- c6f78259-1d6b-4369-a2ac-efe89a2c2819
Device Description
Blood Grouping Reagent Anti-k (KEL2); Seraclone Murine Monoclonal (Lk1); for tube test; 2 mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| 45309 | Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination | A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] and Kell phenotype [KEL:1,2] of red blood cells, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07611969962464 | GS1 |