DEVICE: corQC EXTEND Standard (10888234001324)
Device Identifier (DI) Information
corQC EXTEND Standard
0066296
In Commercial Distribution
0066296
IMMUCOR, INC.
0066296
In Commercial Distribution
0066296
IMMUCOR, INC.
corQC EXTEND Standard is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a single vial product.
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? |
---|---|---|---|---|
45310 | Multiple immunohaematology test IVD, control |
A collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSF | Kit, Quality Control For Blood Banking Reagents |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK070039 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 1 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f2c709e8-7c5e-426c-858c-822e48c33c97
July 06, 2018
3
April 14, 2016
July 06, 2018
3
April 14, 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
[?]
1-855-466-8267
tech_support@immucor.com
tech_support@immucor.com