Mimix™ Myeloid Cancer Panel gDNA Reference Standard

Primary DI
05056850400021
Brand
Mimix™ Myeloid Cancer Panel gDNA Reference Standard
Company
REVVITY DISCOVERY LIMITED
Model
HD829-IVD
Catalog number
HD829-IVD
Device description
The Mimix™ Myeloid Cancer Panel gDNA reference standard is a cell line derived control material that contains 22 variants across 19 genes relevant to myeloid cancer. 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
Single use
true

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056850400021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056850400021050568504000215056850400021

GMDN Terms#

Term, Definition table
TermDefinition
Cancer-related multiple gene mutation profile IVD, controlA 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 table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
345534338
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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05056850400007Mimix™ OncoSpan FFPE Reference StandardHD832-IVDHD832-IVD2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardHD827-IVDHD827-IVD2025-06-05

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