Identity
- Trade Name
- Capture-R Ready Indicator Red Cells FDA UDI
- Generic Name
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody FDA UDI
- Device Name
- Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells. FDA UDI
- Model / Reference
- 0066907 FDA UDI
- Description
- Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells. FDA UDI
Identifiers
- Catalog Number
- 0066907 FDA UDI
- Primary DI / UDI-DI
- 10888234002307 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 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: Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Capture-R Ready Indicator Red Cells by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK020053 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 3995a7bd-73af-48f0-8abe-bbd5f0fa69cb 35 fields · synced Jun 6, 2026