FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-IgG,-C3d (Polyspecific) (Murine Monoclonal) (Green) Gamma-clone
DI: 10888234001676
·
Model: 0409703
·
IMMUCOR, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anti-IgG,-C3d (Polyspecific) (Murine Monoclonal) (Green) Gamma-clone
- Primary DI
- 10888234001676
- Version / Model
- 0409703
- Catalog Number
- 0409703
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 43f86486-31d1-4f83-a97a-7e1d3ac6ae32
Device Description
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is three (3) vials of reagent. The color of the liquid reagent is green.
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 |
|---|---|---|---|---|
| 52723 | Monospecific anti-complement component C3d (anti-C3d) IVD, antibody | One or multiple immunoglobulins capable of binding to C3d complement components fixed to red blood cells and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitisation by complement C3d, using an agglutination technique. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234001676 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius