FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHOTM Sera Anti-D (DVI) Blood Grouping Reagent
DI: 10758750030323
·
Model: 6904624
·
ALBA BIOSCIENCE LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHOTM Sera Anti-D (DVI) Blood Grouping Reagent
- Primary DI
- 10758750030323
- Version / Model
- 6904624
- Company Name
- ALBA BIOSCIENCE LIMITED
- Labeler DUNS
- 516536641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-29
- Public Version
- 5
- Public Version Date
- 2023-06-14
- Public Version Status
- Update
- Public Device Record Key
- 4030c839-e94e-4616-a528-be92d20e74bc
Device Description
The Anti-D (Monoclonal) reagent (Anti-RH1) is for the qualitative in vitro detection of human RhD positive red blood cells by the direct agglutination test. This Anti-D reagent will detect D category DVI cells. The Anti-D (Monoclonal) reagent (Anti-RH1) is indicated for the determination of the RhD status for donors and neonates born to Rh negative women for RhIG therapy assessment. This Anti-D (Monoclonal) reagent (Anti-RH1) is not indicated for pre-transfusion testing of patients as the reagent detects partial RhD (DVI) by direct agglutination.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| 52688 | Partial (variant) Rh(D) category VI red blood cell grouping IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for partial (variant) Rh(D) category VI red blood cell antigens from the rhesus system, using an agglutination or solid-phase red blood cell adherence method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750030323 | GS1 |
Customer Contacts
- Phone
- +41225458274
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius