DEVICE: Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum (10888234001577)
Device Identifier (DI) Information
Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
0066905
In Commercial Distribution
0066905
IMMUCOR, INC.
0066905
In Commercial Distribution
0066905
IMMUCOR, INC.
Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No | |
No | |
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No |
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? |
---|---|---|---|---|
56576 | Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination |
A collection of reagents and other associated materials intended to be used in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen using an agglutination method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSS | Supplies, Blood-Bank |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK860017 | 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
17362d65-312e-41f4-bb8b-43f6b7e1dc1f
September 12, 2022
1
September 03, 2022
September 12, 2022
1
September 03, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined