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 2 x 8 strips containing test wells coated with D-positive red blood cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box. FDA UDI
- Model / Reference
- 0006455 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 2 x 8 strips containing test wells coated with D-positive red blood cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box. FDA UDI
Identifiers
- Catalog Number
- 0006455 FDA UDI
- Primary DI / UDI-DI
- 10888234000679 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. · U
- 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.
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 f1754439-1a89-4ea8-8a88-983cf16fbe29 35 fields · synced May 31, 2026