Identity
- Trade Name
- Mimix™ OncoSpan gDNA Reference Standard FDA UDI
- Generic Name
- Cancer-related multiple gene mutation profile IVD, control FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- HD827-IVD FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- HD827-IVD FDA UDI
- Primary DI / UDI-DI
- 05056850400014 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Cancer-related multiple gene mutation profile IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cancer-related multiple gene mutation profile IVD, control
Mimix™ OncoSpan gDNA Reference Standard by Revvity Discovery Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer-related multiple gene mutation profile IVD, control.
- TruSight™ Oncology DNA Control IVD — Illumina, Inc. · Class II
- TruSight™ Oncology RNA Control — Illumina, Inc. · Class II
- Mimix™ Myeloid Cancer Panel gDNA Reference Standard — REVVITY DISCOVERY LIMITED · Class I
- Mimix™ OncoSpan FFPE Reference Standard — REVVITY DISCOVERY LIMITED · Class I
- Mimix™ Quantitative Multiplex FFPE reference standard — REVVITY DISCOVERY LIMITED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Revvity Discovery Limited
Sources (1)
- FDA UDI 2e6ba7ef-53a6-4446-b15e-cae5bd760756 35 fields · synced Jun 8, 2026