Mimix™ Quantitative Multiplex FFPE reference standard

Primary DI
05056850400038
Brand
Mimix™ Quantitative Multiplex FFPE reference standard
Company
REVVITY DISCOVERY LIMITED
Model
HD200-IVD
Catalog number
HD200-IVD
Device description
The Mimix™ Quantitative Multiplex FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from human cancer cell lines. It is intended for quantitative and/or qualitative monitoring using droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use. The gDNA obtained from Quantitative Multiplex FFPE Reference Standard can be used to monitor ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
Published
2025-08-15
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 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
05056850400038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056850400038050568504000385056850400038

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
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 table
Primary DIBrandModelCatalogPublished
05056850400007Mimix™ OncoSpan FFPE Reference StandardHD832-IVDHD832-IVD2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardHD827-IVDHD827-IVD2025-06-05
05056850400021Mimix™ Myeloid Cancer Panel gDNA Reference StandardHD829-IVDHD829-IVD2025-06-05

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