FDA UDI
In Commercial Distribution
🇺🇸 United States
Bovine Serum Albumin 22%
DI: 05060242471520
·
Model: Z305U
·
ALBA BIOSCIENCE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bovine Serum Albumin 22%
- Primary DI
- 05060242471520
- Version / Model
- Z305U
- 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
- 1d96ee52-c0b9-465c-b701-cc97ae12ad65
Device Description
Bovine Serum Albumin 22%.
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
- Yes
- 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 |
|---|---|---|---|---|
| KSG | Media, Potentiating For In Vitro Diagnostic Use | Hematology | 864.9600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52708 | Bovine serum albumin (BSA) immunohaematology reagent IVD | A substance or reactant that is a bovine serum albumin (BSA) solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060242471520 | GS1 | ||||
| Package | 05060242471094 | GS1 | Carton | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +41225458274
- [email protected]