DEVICE: Concentrated Wash (10X) (10888234500407)
Device Identifier (DI) Information
Concentrated Wash (10X)
403622
In Commercial Distribution
403622
IMMUCOR GTI DIAGNOSTICS, INC.
403622
In Commercial Distribution
403622
IMMUCOR GTI DIAGNOSTICS, INC.
For Use with Factor VIII Antibody Screen and PakPlus
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MYP | Test,Platelet Antibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK960059 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
83bccd0b-f681-4a9e-8c13-74b5ff3c743e
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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