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

Serology ToRCH Negative Control (ToRCH Control -)

Name: Serology ToRCH Negative Control (ToRCH Control -)
Brand: Serology ToRCH Negative Control (ToRCH Control -)

ToRCH Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting IgG and IgM antibodies to Cytomegalovirus (CMV), IgG and IgM…

Registry build 21.09.26

ToRCH Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting IgG and IgM antibodies to Cytomegalovirus (CMV), IgG and IgM antibodies to Rubella virus, IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Herpes Simplex Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Rubeola Virus (Measles), IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori, IgG antibodies to Treponema pallidum (Syphilis), IgG and IgM antibodies to the Viral Capsid Antigen of Epstein-Barr virus (EBV VCA) and IgG antibodies to the Viral Polypeptide Nuclear Antigen of Epstein-Barr Virus (EBV EBNA IgG).

2manufacturers in China registered for this device type

1catalogue number

2recalls on this code

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 Serology ToRCH Negative Control (ToRCH Control -)
Listed by	Randox Laboratories Limited, United Kingdom
FDA product code	OHQ
Device type	Multi-Analyte Controls Unassayed
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2020-06-12
Record revised	2020-12-21 (version 2)

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 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Serology ToRCH Negative Control (ToRCH Control -)
Catalogue number	Size	Status
SR10347		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

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2023-11-06	Class III	Process control	A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.	1 unit
2022-08-01	Class II	Process change control	*Update :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient	2 units	2024-12-13

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.