Identity
- Trade Name
- Capture-R Ready-ID Extend I FDA UDI
- Generic Name
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
- Device Name
- Capture-R Ready-ID Extend I is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-positive red cell membranes of 14 group O single donors. FDA UDI
- Model / Reference
- 0006454 FDA UDI
- Description
- Capture-R Ready-ID Extend I is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-positive red cell membranes of 14 group O single donors. FDA UDI
Identifiers
- Catalog Number
- 0006454 FDA UDI
- Primary DI / UDI-DI
- 10888234000662 FDA UDI
- GMDN Term
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
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-ID Extend I by Immucor, Inc. — 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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- Capture-R Ready-Screen (3) — IMMUCOR, INC.
- Capture-R® Ready-Screen® (I and II) — IMMUCOR, INC.
- Capture-R Ready-Screen (I and II) — IMMUCOR, INC.
- 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI e5b290de-1cb6-4072-92f5-5a8a52d7a776 35 fields · synced May 30, 2026