Identity
- Trade Name
- Capture-R Control set FDA UDI
- Generic Name
- Solid-phase red blood cell adherence antibody/antigen IVD FDA UDI
- Device Name
- Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum) are run controls to be used in Capture-R solid phase assays. The Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells. The Capture-R Negative Control Serum does not contain antibodies to red blood cells. This product configuration has one (1) vial of each control, at a volume of 11.5 mL each. FDA UDI
- Model / Reference
- 0066236 FDA UDI
- Description
- Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum) are run controls to be used in Capture-R solid phase assays. The Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells. The Capture-R Negative Control Serum does not contain antibodies to red blood cells. This product configuration has one (1) vial of each control, at a volume of 11.5 mL each. FDA UDI
Identifiers
- Catalog Number
- 0066236 FDA UDI
- Primary DI / UDI-DI
- 10888234001225 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
No
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 Control set by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 5e8946ed-91c5-4f6c-b39d-17d96157c8b9 35 fields · synced Jun 6, 2026