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
03661540952555
GS1

1
117458512 *Terms of Use
The DSQ Alert IC2 Probe Mix contains a chemically synthesized DNA oligonucleotide probe designed to detect the IC2 nucleic acid sequence
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OLD Internal Polymerase Chain Reaction Control, Not Assay Specific
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than -10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5e768534-9895-4c0c-804b-c6975a7eb8b6
December 20, 2022
1
December 12, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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