DEVICE: MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions (03661540951770)
Device Identifier (DI) Information
MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions
800434
In Commercial Distribution
800434
Elitechgroup Mdx LLC
800434
In Commercial Distribution
800434
Elitechgroup Mdx LLC
MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
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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47295 | Chlamydia pneumoniae 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 Chlamydia pneumoniae bacteria in a clinical specimen, using a nucleic acid technique (NAT).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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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
e68235f0-0faf-4bb5-9cfe-57dee002f15c
October 15, 2020
2
September 08, 2020
October 15, 2020
2
September 08, 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 |
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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
[?]
8004532725
mdx@elitechgroup.com
mdx@elitechgroup.com