AccessGUDID - DEVICE: Mimix™ OncoSpan FFPE Reference Standard (05056850400007)

GUDID

Device Identifier (DI) Information

Brand Name: Mimix™ OncoSpan FFPE Reference Standard
Version or Model: HD832-IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HD832-IVD
Company Name: REVVITY DISCOVERY LIMITED

Primary DI Number: 05056850400007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 345534338 *Terms of Use

Device Description: The Mimix™ OncoSpan FFPE reference standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl 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) or 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 OncoSpan FFPE Reference Standard can be used in NGS or ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f0267bd-4938-4f96-8e9b-7d5bd7b48de2
Public Version Date: June 13, 2025
Public Version Number: 1
DI Record Publish Date: June 05, 2025