DEVICE: PakAuto® (10888234500247)

Device Identifier (DI) Information

PakAuto®
PAKAUTO
Not in Commercial Distribution
PAKAUTO
IMMUCOR GTI DIAGNOSTICS, INC.
10888234500247
GS1
December 31, 2018
1
606034197 *Terms of Use
PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
56573 Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
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 enzyme immunoassay (EIA) 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 [?]
BK960059 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

865e14d6-d9b4-40e3-9f7f-6fabd1d931c2
July 28, 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

[?]
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
waukeshatechsupport@immucor.com
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