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

Multichem A1c

Name: Multichem A1c
Brand: Multichem A1c

Catalogue number HB002A, listed by Techno-Path Manufacturing Ltd., Ireland, under Multi-Analyte Controls Unassayed. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

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 Multichem A1c
Listed by	Techno-Path Manufacturing Ltd., Ireland
FDA product code	OHQ
Device type	Multi-Analyte Controls Unassayed
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2022-09-16

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Multichem A1c
Catalogue number	Size	Status
HB002A		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

2 of these are Class II. Class II means a temporary or reversible health consequence. 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
2025-10-17	Class II	Process control	Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.	76 units
2025-10-17	Class II	Process control	Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.	51 units

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.