DEVICE: MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions (03661540951220)
Device Identifier (DI) Information
MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions
M800687
In Commercial Distribution
M800687
Elitechgroup Mdx LLC
M800687
In Commercial Distribution
M800687
Elitechgroup Mdx LLC
"MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrA
gene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 and
has an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm"
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? |
---|---|---|---|---|
61989 | Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple serogroups of species of the genus Legionella (e.g., L. pneumophila, L. longbeachae) in a clinical specimen, using a nucleic acid technique (NAT). Legionella species are associated with pneumonia-like respiratory infection and Legionnaires' disease.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVU | Reagents, Specific, Analyte |
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: less than -10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3e1920e2-b32b-44e3-8850-b25d7d9f39ee
October 15, 2020
2
September 09, 2020
October 15, 2020
2
September 09, 2020
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 |
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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
[?]
8004532725
MDx@elitechgroup.com
MDx@elitechgroup.com