FDA UDI
In Commercial Distribution
🇺🇸 United States
Capture-R Ready-Screen (I and II)
DI: 10888234001201
·
Model: 0066217
·
IMMUCOR, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capture-R Ready-Screen (I and II)
- Primary DI
- 10888234001201
- Version / Model
- 0066217
- Catalog Number
- 0066217
- 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
- 4c207b20-94bf-4506-b771-8d9747acc768
Device Description
Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.
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 | 10888234001201 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius