DEVICE: Concentrated Wash (10X) (10888234500407)

Device Identifier (DI) Information

Concentrated Wash (10X)
403622
In Commercial Distribution
403622
IMMUCOR GTI DIAGNOSTICS, INC.
10888234500407
GS1

1
606034197 *Terms of Use
For Use with Factor VIII Antibody Screen and PakPlus
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
56531 HLA class I antibody screening IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used in screening for one or multiple antibodies to HLA class I antigens in a clinical specimen.
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
No CLOSE

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 25 Degrees Celsius
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Clinically Relevant Size

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

83bccd0b-f681-4a9e-8c13-74b5ff3c743e
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

[?]
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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