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.
10888234001577
GS1

1
061446282 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
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.
Active false
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FDA Product Code

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Product Code Product Code Name
KSS Supplies, Blood-Bank
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK860017 0
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

17362d65-312e-41f4-bb8b-43f6b7e1dc1f
September 12, 2022
1
September 03, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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