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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)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Research and Diagnostic Systems	CT002	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST406	FDA UDI	Class II	Active
Research and Diagnostic Systems	HGB723	FDA UDI	Class II	Active
Research and Diagnostic Systems	72000	FDA UDI	Class II	Active
Research and Diagnostic Systems	3R002	FDA UDI	Class II	Active
Research and Diagnostic Systems	UL002	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D504	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC402	FDA UDI	Class II	Active
Research and Diagnostic Systems	LRR001	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL009	FDA UDI	Class II	Active
Research and Diagnostic Systems	RDKAP1971	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL033	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL024	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST003	FDA UDI	Class II	Active
Research and Diagnostic Systems	LH004	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL031	FDA UDI	Class II	Active
Research and Diagnostic Systems	RI004	FDA UDI	Class II	Active
R&D CBC-XR Hematology Control	XR004	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC236L	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC728	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL030	FDA UDI	Class II	Active
Research and Diagnostic Systems	3KD02	FDA UDI	Class II	Active
Research and Diagnostic Systems	SR002	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00LX	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D502	FDA UDI	Class II	Active
Research and Diagnostic Systems	3KC11	FDA UDI	Class II	Active
Research and Diagnostic Systems	X003	FDA UDI	Class II	Active
Research and Diagnostic Systems	3K303X	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL015	FDA UDI	Class II	Active
Research and Diagnostic Systems	NEK11	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST004	FDA UDI	Class II	Active
Research and Diagnostic Systems	HC725	FDA UDI	Class II	Active
Research and Diagnostic Systems	HGB722	FDA UDI	Class II	Active
Research and Diagnostic Systems	X002	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST207	FDA UDI	Class II	Active
Research and Diagnostic Systems	WBC00S	FDA UDI	Class II	Active
Research and Diagnostic Systems	72002	FDA UDI	Class II	Active
Research and Diagnostic Systems	SR003	FDA UDI	Class II	Active
Research and Diagnostic Systems	PTE004	FDA UDI	Class II	Active
Research and Diagnostic Systems	RP403	FDA UDI	Class II	Active
Research and Diagnostic Systems	UL001	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL035	FDA UDI	Class II	Active
Research and Diagnostic Systems	72004	FDA UDI	Class II	Active
Research and Diagnostic Systems	72003X	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC404	FDA UDI	Class II	Active
Research and Diagnostic Systems	RA003	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC235	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL034	FDA UDI	Class II	Active
Research and Diagnostic Systems	FH102	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST001	FDA UDI	Class II	Active

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