DEVICE: IFA: Legionella Mosaic 4 (IgAGM) (04049016105923)
Device Identifier (DI) Information
IFA: Legionella Mosaic 4 (IgAGM)
FI 2150-1005-4 P
Not in Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-4 P
Not in Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
No description.
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? |
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62354 | Multiple Legionella species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to multiple species of Legionella in a clinical specimen, using a fluorescent immunoassay method. Legionella species intended to be detected may include Legionella pneumophila, L. longbeachae, L. jordanis, L. bozemanii, L. gormanii, L. micdadei, and L. dumoffii which are associated with pneumonia-like respiratory infection and 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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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
cd0dd328-ffce-4112-a216-4bc2a8d141bb
September 14, 2018
3
October 10, 2016
September 14, 2018
3
October 10, 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
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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