DEVICE: ACCURUN® (00816784020437)
Device Identifier (DI) Information
ACCURUN®
2015-0087
In Commercial Distribution
2015-0087
Lgc Clinical Diagnostics, Inc.
2015-0087
In Commercial Distribution
2015-0087
Lgc Clinical Diagnostics, Inc.
ACCURUN 145 CMV IgG 1 x 1.0 mL
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? |
---|---|---|---|---|
32483 | Cytomegalovirus (CMV) antigen IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen.
|
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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BK930027 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fe7f4786-16f8-4f3d-8a22-2f0474b7385e
July 25, 2023
5
September 27, 2016
July 25, 2023
5
September 27, 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
[?]
No Customer Contact currently defined