DEVICE: Capture-R Ready Indicator Red Cells (10888234002307)
Device Identifier (DI) Information
Capture-R Ready Indicator Red Cells
0066907
In Commercial Distribution
0066907
IMMUCOR, INC.
0066907
In Commercial Distribution
0066907
IMMUCOR, INC.
Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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46948 | Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody |
One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, using an agglutination or solid-phase red blood cell adherence method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KSF | Kit, Quality Control For Blood Banking Reagents |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK020053 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3995a7bd-73af-48f0-8abe-bbd5f0fa69cb
September 12, 2022
1
September 03, 2022
September 12, 2022
1
September 03, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined