FDA UDI
In Commercial Distribution
🇺🇸 United States
Capture-R Select
DI: 10888234001553
·
Model: 0066903
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capture-R Select
- Primary DI
- 10888234001553
- Version / Model
- 0066903
- Catalog Number
- 0066903
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-03
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- 24c60f82-e0b9-447b-9edd-2e5bb42c31e5
Device Description
The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSZ | System, Test, Automated Blood Grouping And Antibody | Hematology | 864.9175 | 2 |
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 | 10888234001553 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK040024 | 0 |