FDA UDI
In Commercial Distribution
🇺🇸 United States
Seraclone® Anti-D (RH1)
DI: 07611969950263
·
Model: 802042100
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Seraclone® Anti-D (RH1)
- Primary DI
- 07611969950263
- Version / Model
- 802042100
- Catalog Number
- 802042100
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e0eb7ff9-f7ac-4c20-ac29-581c29099d92
Device Description
Blood Grouping Reagent Anti-D (RH1) 226; Seraclone® Human Monoclonal (BS226); for tube test; 10x10ml
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 |
|---|---|---|---|---|
| 52647 | Anti-Rh(D) 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 Rh(D) [RH001] red blood cell antigens from the rhesus system, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07611969950263 | GS1 |
Customer Contacts
- Phone
- 800-224-6723
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius