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Mimix™ Quantitative Multiplex FFPE reference standard

FDA UDI

Class I (US FDA UDI)

by Revvity Discovery Limited

Identity

Trade Name
Mimix™ Quantitative Multiplex FFPE reference standard FDA UDI
Generic Name
Cancer-related multiple gene mutation profile IVD, control FDA UDI
Device Name
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. FDA UDI
Model / Reference
HD200-IVD FDA UDI
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. FDA UDI

Identifiers

Catalog Number
HD200-IVD FDA UDI
Primary DI / UDI-DI
05056850400038 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™ Quantitative Multiplex FFPE 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Revvity Discovery Limited

Sources (1)

  • FDA UDI 33497f4d-da64-467c-9a8f-067629e8bcd3 35 fields · synced May 30, 2026