What is FDA product code OHQ?

A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.

Clinical Chemistry › Test SystemsMulti-Analyte Controls Unassayed

Mimix™ Geni™ Negative Ffpe Reference Standard

Name: Mimix™ Geni™ Negative Ffpe Reference Standard
Brand: Mimix™ Geni™ Negative Ffpe Reference Standard

The Mimix™ Geni™ Negative FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from the GM24385 Genome-in-a-Bottle…

Registry build 21.09.26

The Mimix™ Geni™ Negative FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from the GM24385 Genome-in-a-Bottle Consortium (GIAB) cell line, with no additional genomic interventions. 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 oncogenic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use. The gDNA or RNA obtained from Mimix Geni Negative FFPE Reference Standard can be used to monitor NGS or ddPCR workflows, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1).

Chinese manufacturers registered for FDA product code OHQ
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Phase Scientific (Shenzhen) Company Limited	Shenzhen	Guangdong	Repacker / relabeller	8

Record

Regulatory record for Mimix™ Geni™ Negative Ffpe Reference Standard
Listed by	Revvity Discovery Limited, United Kingdom
FDA product code	OHQ
Device type	Multi-Analyte Controls Unassayed
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2026-03-27

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Mimix™ Geni™ Negative Ffpe Reference Standard
Catalogue number	Size	Status
HD876-IVD		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Exact Diagnostics	Exact Diagnostics	64
NATtrol™	Zeptometrix LLC.	54
QC Sets and Panels: Helix Elite™	Microbiologics, Inc.	51
Helix Elite™ Molecular Standards: Inactivated Standard	Microbiologics, Inc.	41
Multichem S Plus	Techno-Path Manufacturing Ltd.	35
Virotrol	Bio-Rad Laboratories Inc.	27
Helix Elite™ Molecular Standards: Synthetic Standard	Microbiologics, Inc.	25
Multichem IA Plus	Techno-Path Manufacturing Ltd.	17
D3	Diagnostic Hybrids, Inc.	14
Liquichek	Bio-Rad Laboratories Inc.	10
Multichem IA	Techno-Path Manufacturing Ltd.	8
QC Sets and Panels: Kwik-Stik™ 2 Pack	Microbiologics, Inc.	8

Showing 12 of 107. All products under Multi-Analyte Controls Unassayed

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.