DEVICE: MGB Alert Enterovirus v.2.0 Primer Mix ASR, 48 rxns (03661540952104)
Device Identifier (DI) Information
MGB Alert Enterovirus v.2.0 Primer Mix ASR, 48 rxns
M800708
In Commercial Distribution
M800708
Elitechgroup Mdx LLC
M800708
In Commercial Distribution
M800708
Elitechgroup Mdx LLC
DSQ Alert Enterovirus 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 enterovirus RNA genome. The mix consists of a total of 14.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 138 bp region of the 5’-UTR of enterovirus.
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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48692 | Enterovirus nucleic acid (serotypes 68-71) 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 one or multiple enteroviruses from serotypes 68-71 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
f432daef-3f84-4104-8b0d-55078f2fa6b7
November 14, 2023
2
September 21, 2023
November 14, 2023
2
September 21, 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