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

DBS Controls M2

Name: DBS Controls M2
Brand: DBS Controls M2

The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity. This product has no qualitative or quantitative assigned…

Registry build 21.09.26

The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity. This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen.

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 DBS Controls M2
Listed by	Wallac OY, Finland
FDA product code	OHQ
Device type	Multi-Analyte Controls Unassayed
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2023-04-17

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature -30 to -16 °C

Catalogue Numbers

Catalogue numbers for DBS Controls M2
Catalogue number	Size	Status
3255-0010		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.