FDA UDI
In Commercial Distribution
🇺🇸 United States
ALBAcheck - BGS Monoclonal Control
DI: 05060242472473
·
Model: Z271U
·
ALBA BIOSCIENCE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- ALBAcheck - BGS Monoclonal Control
- Primary DI
- 05060242472473
- Version / Model
- Z271U
- Company Name
- ALBA BIOSCIENCE LIMITED
- Labeler DUNS
- 516536641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 2
- Public Version Date
- 2022-03-31
- Public Version Status
- Update
- Public Device Record Key
- 9c2bddbe-8bc4-409e-87f0-51c09e81c4d7
Device Description
ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunction with Alba Bioscience Limited monoclonal blood grouping reagents (where referenced in the reagent IFU).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSF | Kit, Quality Control For Blood Banking Reagents | Hematology | 864.9650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52705 | Antisera matrix (non-reactive) IVD, control | A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060242472459 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 05060242472473 | GS1 | ||||
| Package | 05060242472442 | GS1 | 10 | In Commercial Distribution | ||
| Previous | 05060242471513 | GS1 |
Customer Contacts
- Phone
- +41225458274
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius