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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 (183)

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Device	Model / Reference	Registries	Class	Status
Research and Diagnostic Systems	RI003	FDA UDI	Class II	Active
Research and Diagnostic Systems	HGB727	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST208	FDA UDI	Class II	Active
Research and Diagnostic Systems	RCL002	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC729	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC727	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL020	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL037	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC236H	FDA UDI	Class II	Active
Research and Diagnostic Systems	HCL001	FDA UDI	Class II	Active
Research and Diagnostic Systems	BF002	EUDAMEDFDA UDI	Class II	Active
Research and Diagnostic Systems	CT001	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00NX	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL026	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL017	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00N	FDA UDI	Class II	Active
Research and Diagnostic Systems	PTE5X	FDA UDI	Class II	Active
Research and Diagnostic Systems	XN004	FDA UDI	Class II	Active
Research and Diagnostic Systems	CT003X	EUDAMEDFDA UDI	Class II	Active
Research and Diagnostic Systems	BFI001	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00H	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D508	FDA UDI	Class II	Active
Research and Diagnostic Systems	FH1031	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC204	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL019	FDA UDI	Class II	Active
Research and Diagnostic Systems	RDXH01	FDA UDI	Class II	Active
Research and Diagnostic Systems	FH103	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D501	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D506US	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC722	FDA UDI	Class II	Active
R & D Systems, Inc. CBC-PIX Hematology Control	P002	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL010P	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D505	FDA UDI	Class II	Active
Research and Diagnostic Systems	3R001	FDA UDI	Class II	Active
Research and Diagnostic Systems	CEP01	FDA UDI	Class II	Active
Research and Diagnostic Systems	8CP33	FDA UDI	Class II	Active
Research and Diagnostic Systems	FH1032	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL029	FDA UDI	Class II	Active
R&D CBC-XR Hematology Control	XR002	FDA UDI	Class II	Active
Research and Diagnostic Systems	3KD04	FDA UDI	Class II	Active
Research and Diagnostic Systems	PTE006	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL018	FDA UDI	Class II	Active
Research and Diagnostic Systems	PTE6X	EUDAMEDFDA UDI	Class II	Active
Research and Diagnostic Systems	SED002	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00S	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D503RX	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D503	FDA UDI	Class II	Active
Research and Diagnostic Systems	FH1033	FDA UDI	Class II	Active
Research and Diagnostic Systems	XER003X	FDA UDI	Class II	Active
Research and Diagnostic Systems	72001	FDA UDI	Class II	Active

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