DEVICE: DSQ Alert Internal Control Set IC2 (03661540952555)
Device Identifier (DI) Information
DSQ Alert Internal Control Set IC2
800741
In Commercial Distribution
800741
Elitechgroup Mdx LLC
800741
In Commercial Distribution
800741
Elitechgroup Mdx LLC
The DSQ Alert IC2 Probe Mix contains a chemically synthesized DNA oligonucleotide probe designed to detect the IC2 nucleic acid sequence
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? |
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60094 | Exogenous DNA/RNA internal control IVD, kit |
A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific |
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
5e768534-9895-4c0c-804b-c6975a7eb8b6
December 20, 2022
1
December 12, 2022
December 20, 2022
1
December 12, 2022
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
[?]
No Customer Contact currently defined