Identity
- Trade Name
- Capture-R Select FDA UDI
- Generic Name
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 0066903 FDA UDI
- 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). FDA UDI
Identifiers
- Catalog Number
- 0066903 FDA UDI
- Primary DI / UDI-DI
- 10888234001553 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Solid-phase red blood cell adherence antibody/antigen IVD
Capture-R Select by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Solid-phase red blood cell adherence antibody/antigen IVD.
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Cleared under the same submission
BK040024 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 24c60f82-e0b9-447b-9edd-2e5bb42c31e5 35 fields · synced May 30, 2026