DEVICE: PakPlus® (10888234500254)
Device Identifier (DI) Information
PakPlus®
PAKPLUS
In Commercial Distribution
PAKPLUS
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS
In Commercial Distribution
PAKPLUS
IMMUCOR GTI DIAGNOSTICS, INC.
The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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56526 | HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used in screening a clinical specimen for one or multiple antibodies to HLA class I antigens, using solid phase antigens together with an enzyme (EIA) immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MYP | Test,Platelet Antibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK140163 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
09b752bb-a09d-4982-be75-be5f233255e7
July 31, 2023
4
July 08, 2016
July 31, 2023
4
July 08, 2016
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
[?]
855-466-8267
info@immucor.com
info@immucor.com