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 II Positive Control (Serology II Control +)

Name: Serology II Positive Control (Serology II Control +)
Brand: Serology II Positive Control (Serology II Control +)

Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core…

Registry build 21.09.26

Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology II Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.

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 II Positive Control (Serology II 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	2020-05-11
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 II Positive Control (Serology II Control +)
Catalogue number	Size	Status
SR10353		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.