FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-Human Globulin Anti-IgG (Rabbit) (Green)
DI: 05060242472404
·
Model: Z357U
·
ALBA BIOSCIENCE LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Anti-Human Globulin Anti-IgG (Rabbit) (Green)
- Primary DI
- 05060242472404
- Version / Model
- Z357U
- Company Name
- ALBA BIOSCIENCE LIMITED
- Labeler DUNS
- 516536641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 3
- Public Version Date
- 2022-03-31
- Public Version Status
- Update
- Public Device Record Key
- b55403a6-ff61-465f-b952-ecada2cd8473
Device Description
Anti-Human Globulin Anti-IgG is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG. Anti-Human Globulin Anti-IgG is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG.
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 |
|---|---|---|---|---|
| 46948 | Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody | One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, 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 |
|---|---|---|---|---|---|---|
| Package | 05060242472411 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 05060242472404 | GS1 | ||||
| Package | 05060242472428 | GS1 | 3 | In Commercial Distribution | ||
| Package | 05060242472435 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +41225458274
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius