FDA UDI
In Commercial Distribution
🇺🇸 United States
ALBAcyte A1 Cells
DI: 05060242471124
·
Model: Z401U
·
ALBA BIOSCIENCE LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALBAcyte A1 Cells
- Primary DI
- 05060242471124
- Version / Model
- Z401U
- Company Name
- ALBA BIOSCIENCE LIMITED
- Labeler DUNS
- 516536641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-14
- Public Version
- 4
- Public Version Date
- 2022-03-31
- Public Version Status
- Update
- Public Device Record Key
- c2efeacc-5827-41b9-abe4-03309c6a3861
Device Description
2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte A1 Cells, for tube technique.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 52673 | Group A1 Rh (D) negative reagent red blood cell IVD, antigen | A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group A1 Rh(D) negative. These reagent cells are positive for blood group antigen A1 [ABO004] and negative for blood group antigen Rh(D) [RH001]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060242471124 | GS1 |
Customer Contacts
- Phone
- +41225458274
- [email protected]