FDA UDI
In Commercial Distribution
🇺🇸 United States
Solidscreen II Anti-D (RH1) Blend
DI: 07611969951512
·
Model: 806530100
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solidscreen II Anti-D (RH1) Blend
- Primary DI
- 07611969951512
- Version / Model
- 806530100
- Catalog Number
- 806530100
- 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
- 2014-09-17
- Public Version
- 3
- Public Version Date
- 2021-05-24
- Public Version Status
- Update
- Public Device Record Key
- 19854336-11ce-4051-9f8c-b52f05ed7efd
Device Description
Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with TANGO instruments; 5ml
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 |
|---|---|---|---|---|
| 58904 | Partial (variant) Rh(D) category VI/weak Rh(D) red 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 the presence of partial (variant) Rh(D) category VI red blood cell antigens or weak expression of the Rh(D) antigens from the rhesus system, by red blood cells that have been initially screened as Rh(D) negative, 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 | 07611969951512 | GS1 |
Customer Contacts
- Phone
- 800-224-6723
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius