Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard
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Basic Information
- Brand Name
- Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard
- Primary DI
- 05056850400052
- Version / Model
- HD852-IVD
- Catalog Number
- HD852-IVD
- Company Name
- REVVITY DISCOVERY LIMITED
- Labeler DUNS
- 345534338
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-27
- Public Version
- 1
- Public Version Date
- 2026-04-06
- Public Version Status
- New
- Public Device Record Key
- 2627a005-022c-48fc-bb6c-b83f667cb698
Device Description
The Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl made from a multiplex of 7 engineered cell lines from the GM24385 Genome in a Bottle Consortium Cell line (GIAB), containing 5 single nucleotide polymorphisms (SNPs) and 2 gene fusions. It is intended for quantitative and/or qualitative monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use. The gDNA or RNA obtained from Geni OncoMix 1 DNA/RNA FFPE Reference Standard can be used to monitor NGS or ddPCR workflows, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66133 | Cancer-related multiple gene mutation profile IVD, control | A material which is used to verify the performance of an assay intended to be used for genomic profiling/screening of multiple genes associated with cancer to detect specific types of mutations [e.g., single nucleotide variants (SNVs), insertions, deletions, fusions, translocations and/or copy number variations (CNVs)] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056850400052 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius