Mimix™ OncoSpan gDNA Reference Standard
- Primary DI
- 05056850400014
- Brand
- Mimix™ OncoSpan gDNA Reference Standard
- Company
- REVVITY DISCOVERY LIMITED
- Model
- HD827-IVD
- Catalog number
- HD827-IVD
- Device description
- The Mimix™ OncoSpan gDNA reference standard is a commutable control material comprising a mixture of genomic DNA (gDNA) derived from human cancer cell lines, containing more than 380 variants across 152 cancer genes. 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 mutations in human gDNA samples for in vitro diagnostic use. This control can be used to monitor NGS and ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
- Published
- 2025-06-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| OHQ | Multi-Analyte Controls Unassayed |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05056850400014 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05056850400014 | 05056850400014 | 5056850400014 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 345534338
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 05056850400038 | Mimix™ Quantitative Multiplex FFPE reference standard | HD200-IVD | HD200-IVD | 2025-08-15 |
| 05056850400007 | Mimix™ OncoSpan FFPE Reference Standard | HD832-IVD | HD832-IVD | 2025-06-05 |
| 05056850400021 | Mimix™ Myeloid Cancer Panel gDNA Reference Standard | HD829-IVD | HD829-IVD | 2025-06-05 |
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