DEVICE: Alethia™ Pertussis (00840733102226)
Device Identifier (DI) Information
Alethia™ Pertussis
480750
In Commercial Distribution
480750
MERIDIAN BIOSCIENCE, INC.
480750
In Commercial Distribution
480750
MERIDIAN BIOSCIENCE, INC.
The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.
The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.
Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.
Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Device Characteristics
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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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50513 | Bordetella pertussis 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 Bordetella pertussis in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.
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FDA Product Code
[?]Product Code | Product Code Name |
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OZZ | Bordetella Pertussis Dna Assay System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
33974dea-bc45-472c-b54e-5527f0b4e1c2
February 08, 2019
1
January 08, 2019
February 08, 2019
1
January 08, 2019
Alternative and Additional Identifiers Additional Identifiers
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined