FDA UDI
In Commercial Distribution
🇺🇸 United States
IH-Card AHG Anti-IgG,-C3d
DI: 07611969952151
·
Model: 813411100
·
Bio-Rad Medical Diagnostics GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IH-Card AHG Anti-IgG,-C3d
- Primary DI
- 07611969952151
- Version / Model
- 813411100
- Catalog Number
- 813411100
- Company Name
- Bio-Rad Medical Diagnostics GmbH
- Labeler DUNS
- 312576506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-20
- Public Version
- 3
- Public Version Date
- 2021-05-24
- Public Version Status
- Update
- Public Device Record Key
- 3263889d-3f29-4387-b4bc-03ce4c567fbf
Device Description
Anti-Human Globulin Anti-IgG, -C3d; Polyspecific; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 48 cards of 6 microtubes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52731 | Polyspecific antihuman globulin/complement IVD, antibody | One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies and/or complement components when fixed to red blood cells. This solution is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin and/or complement components, 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 |
|---|---|---|---|---|---|---|
| Primary | 07611969952151 | GS1 |
Customer Contacts
- Phone
- 800-224-6723
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Upright position
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius