Mimix™ Geni™ Negative FFPE Reference Standard
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Basic Information
- Brand Name
- Mimix™ Geni™ Negative FFPE Reference Standard
- Primary DI
- 05056850400069
- Version / Model
- HD876-IVD
- Catalog Number
- HD876-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
- f49e49b4-1848-4f38-a6ed-8e1efd3a3f22
Device Description
The Mimix™ Geni™ Negative FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from the GM24385 Genome-in-a-Bottle Consortium (GIAB) cell line, with no additional genomic interventions. It is intended for qualitative and/or quantitative monitoring of next generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic oncogenic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use. The gDNA or RNA obtained from Mimix Geni Negative 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 | 05056850400069 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius