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RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Last updated May 26, 2026

What RESEARCH AND DIAGNOSTIC SYSTEMS, INC. makes

The company produces in vitro diagnostic (IVD) controls and calibrators for full blood count assays, including reagents for erythrocyte sedimentation rate (ESR) and glucose/haemoglobin (Hb) measurements. It also supplies kits for reticulocyte and T lymphocyte analysis via flow cytometry, as well as foeto-maternal haemorrhage detection using fluorescent methods and CD34 cell marker identification through enzyme immunohistochemistry.

All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Research and Diagnostic Systems, Inc. manufacture?

Research and Diagnostic Systems, Inc. specializes in in vitro diagnostic (IVD) products, primarily controls and calibrators for full blood count assays. Their portfolio also includes kits for reticulocyte and T lymphocyte analysis using flow cytometry, foeto-maternal haemorrhage detection via fluorescent methods, and CD34 cell marker identification through enzyme immunohistochemistry. These devices are designed to support laboratory testing and diagnostics.

Where is Research and Diagnostic Systems, Inc. based?

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and device listings confirm its operational base within the country.

Which regulatory registries list devices from Research and Diagnostic Systems, Inc.?

The company’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class II devices, which includes all of Research and Diagnostic Systems, Inc.’s listed products, ensuring traceability and compliance with U.S. regulatory requirements.

How are the devices manufactured by Research and Diagnostic Systems, Inc. classified under FDA regulations?

All devices produced by Research and Diagnostic Systems, Inc. fall under FDA Class II classification. This classification applies to moderate-risk medical devices that require special controls to ensure their safety and effectiveness, such as IVD controls and calibrators used in laboratory settings.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: bio-techne.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-428-4246
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 087248183

Catalogue (180)

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Device	Model / Reference	Registries	Class	Status
Research and Diagnostic Systems	DEP00	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC502	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL027	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL011	FDA UDI	Class II	Active
Research and Diagnostic Systems	HGB729	FDA UDI	Class II	Active
Research and Diagnostic Systems	3K303	FDA UDI	Class II	Active
Research and Diagnostic Systems	FH101	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL036	FDA UDI	Class II	Active
Research and Diagnostic Systems	5D003	FDA UDI	Class II	Active
Research and Diagnostic Systems	SQC002	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL032	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST002	FDA UDI	Class II	Active
Research and Diagnostic Systems	SED004	FDA UDI	Class II	Active
Research and Diagnostic Systems	SR0012	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL021	FDA UDI	Class II	Active
Research and Diagnostic Systems	D3D04	FDA UDI	Class II	Active
R&D CBC-DH Hematology Control	DH004	FDA UDI	N/A	Unknown
Research and Diagnostic Systems	HGB724	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC302	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL012	FDA UDI	Class II	Active
Research and Diagnostic Systems	8CP12	FDA UDI	Class II	Active
Research and Diagnostic Systems	3K302	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL025	FDA UDI	Class II	Active
Research and Diagnostic Systems	LRC001	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D518	FDA UDI	Class II	Active
Research and Diagnostic Systems	HCLNH3	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC504	FDA UDI	Class II	Active
Research and Diagnostic Systems	RP401	FDA UDI	Class II	Active
Research and Diagnostic Systems	RCL001	FDA UDI	Class II	Active
Research and Diagnostic Systems	8CP01	FDA UDI	Class II	Active
Research and Diagnostic Systems	LH002	FDA UDI	Class II	Active
Research and Diagnostic Systems	8CP13US	FDA UDI	Class II	Active
Research and Diagnostic Systems	RDXH03	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D507	FDA UDI	Class II	Active
Research and Diagnostic Systems	72001X	FDA UDI	Class II	Active
Research and Diagnostic Systems	8CP15	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL016	FDA UDI	Class II	Active
Research and Diagnostic Systems	HGB725	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D515	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC723	FDA UDI	Class II	Active
Research and Diagnostic Systems	X003X	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC202	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL010	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC724	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00HX	FDA UDI	Class II	Active
Research and Diagnostic Systems	SY003	FDA UDI	Class II	Active
Research and Diagnostic Systems	3KC12	FDA UDI	Class II	Active
R&D CBC-DH Hematology Control	DH002	FDA UDI	N/A	Unknown
Research and Diagnostic Systems	3D517	FDA UDI	Class II	Active
Research and Diagnostic Systems	RI003	FDA UDI	Class II	Active

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