DEVICE: AvertD™ BioFilmChip Microarray Magazine (10850009370218)
Device Identifier (DI) Information
AvertD™ BioFilmChip Microarray Magazine
03-1560-01
In Commercial Distribution
03-1560-01
AUTOGENOMICS, INC
03-1560-01
In Commercial Distribution
03-1560-01
AUTOGENOMICS, INC
The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
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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67125 | Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the risk of developing opioid use disorder (OUD) based on multiple disease-associated genotypes, using a nucleic acid technique (NAT). These genotypes may include, but are not limited to, variants of the methylenetetrahydrofolate reductase (MTHFR), mu-opioid receptor, galanin (GAL) and ABCB1 genes.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QZH | Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P230032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
afdf3a26-2da4-4de7-bf6f-317690964a2b
June 10, 2024
1
May 31, 2024
June 10, 2024
1
May 31, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30850009370212 | 4 | 10850009370218 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
760-477-2248
techsupport@autogenomics.com
techsupport@autogenomics.com