DEVICE: Microgen Legionella (05060446290040)
Device Identifier (DI) Information
Microgen Legionella
M45CE
In Commercial Distribution
MICROGEN BIOPRODUCTS LIMITED
M45CE
In Commercial Distribution
MICROGEN BIOPRODUCTS LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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51055 | Legionella pneumophila antigen IVD, kit, agglutination |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fe3e6cfe-dce6-4d05-8c8b-9445af102072
March 29, 2018
2
June 30, 2016
March 29, 2018
2
June 30, 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