Identity
- Trade Name
- Capture-R Ready-Screen 3 FDA UDI
- Generic Name
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
- Device Name
- Capture-R Ready-Screen (3) 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. FDA UDI
- Model / Reference
- 0066901 FDA UDI
- Description
- Capture-R Ready-Screen (3) 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. FDA UDI
Identifiers
- Catalog Number
- 0066901 FDA UDI
- Primary DI / UDI-DI
- 10888234001539 FDA UDI
- FDA Product Code
- QHT FDA UDI
- GMDN Term
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 660.30 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 Ready-Screen 3 by Immucor, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Capture-R Ready-Screen (I and II) — IMMUCOR, INC.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 3db96cb6-100b-4972-9e52-152ef796c200 34 fields · synced May 30, 2026