DEVICE: PakPlus® (10888234500254)

Device Identifier (DI) Information

PakPlus®
PAKPLUS
In Commercial Distribution
PAKPLUS
IMMUCOR GTI DIAGNOSTICS, INC.
10888234500254
GS1

1
606034197 *Terms of Use
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.
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Device Characteristics

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

[?]
Product Code Product Code Name
MYP Test,Platelet Antibody
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK140163 0
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

09b752bb-a09d-4982-be75-be5f233255e7
July 31, 2023
4
July 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
855-466-8267
info@immucor.com
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