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Mimix™ Myeloid Cancer Panel gDNA Reference Standard
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Mimix™ Myeloid Cancer Panel gDNA Reference Standard FDA UDI
- Generic Name
- Cancer-related multiple gene mutation profile IVD, control FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- HD829-IVD FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- HD829-IVD FDA UDI
- Primary DI / UDI-DI
- 05056850400021 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™ Myeloid Cancer Panel 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.
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- TruSight™ Oncology RNA Control — Illumina, Inc. · Class II
- Mimix™ OncoSpan FFPE Reference Standard — REVVITY DISCOVERY LIMITED · Class I
- Mimix™ OncoSpan gDNA 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 3e597f30-8d67-4e54-b867-4be50bf1fd18 35 fields · synced May 30, 2026