DEVICE: DSQ Alert™ Parechovirus v2.0 Primer Mix ASR (03661540952692)
Device Identifier (DI) Information
DSQ Alert™ Parechovirus v2.0 Primer Mix ASR
M800758
In Commercial Distribution
M800758
Elitechgroup Mdx LLC
M800758
In Commercial Distribution
M800758
Elitechgroup Mdx LLC
DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 130 bp region of the 5’-UTR of parechovirus.
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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50002 | Human parechovirus (HPeV) nucleic acid IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from one or multiple strains of Human parechovirus (HPeV) in a clinical specimen.
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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
beb5394b-ff03-4791-8d30-322f01790885
November 14, 2023
2
October 05, 2023
November 14, 2023
2
October 05, 2023
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