FDA UDI
In Commercial Distribution
🇺🇸 United States
Capture-R Ready-ID Extend II
DI: 10888234000686
·
Model: 0006456
·
IMMUCOR, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capture-R Ready-ID Extend II
- Primary DI
- 10888234000686
- Version / Model
- 0006456
- Catalog Number
- 0006456
- 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
- 3
- Public Version Date
- 2021-07-08
- Public Version Status
- Update
- Public Device Record Key
- a78bba64-f0e1-41c1-b1c8-cd8493d9afea
Device Description
Capture-R Ready-ID Extend II is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-negative red blood cell membranes of 14 group O single donors.
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 |
|---|---|---|---|---|
| 58814 | Solid-phase red blood cell adherence antibody/antigen IVD | A microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a 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 | 10888234000686 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius