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 used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch. FDA UDI
- Model / Reference
- 0066804 FDA UDI
- Description
- Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch. FDA UDI
Identifiers
- Catalog Number
- 0066804 FDA UDI
- Primary DI / UDI-DI
- 10888234001423 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-Screen (3) by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 0351651d-96e3-4784-974d-670376e2a6b2 35 fields · synced May 30, 2026