Question 1

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

Accepted Answer

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.

Question 2

Where is Research and Diagnostic Systems, Inc. based?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Research and Diagnostic Systems	FC234H	FDA UDI	Class II	Active
Research and Diagnostic Systems	SY003X	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL028	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC238	FDA UDI	Class II	Active
Research and Diagnostic Systems	SQC001	FDA UDI	Class II	Active
Research and Diagnostic Systems	SR0011	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL013	FDA UDI	Class II	Active
R&D CBC-XR Hematology Control	XR010	FDA UDI	Class II	Active
Research and Diagnostic Systems	CEP03	FDA UDI	Class II	Active
Research and Diagnostic Systems	72000	FDA UDI	Class II	Unknown
Research and Diagnostic Systems	CL022	FDA UDI	Class II	Active
Research and Diagnostic Systems	3D505T	FDA UDI	Class II	Active
Research and Diagnostic Systems	72003	FDA UDI	Class II	Active
Research and Diagnostic Systems	SR002X	FDA UDI	Class II	Active
Research and Diagnostic Systems	HCT004	EUDAMEDFDA UDI	Class II	Active
Research and Diagnostic Systems	3D516	FDA UDI	Class II	Active
Research and Diagnostic Systems	4R001	FDA UDI	Class II	Active
Research and Diagnostic Systems	LRP001	FDA UDI	Class II	Active
Research and Diagnostic Systems	CT003	FDA UDI	Class II	Active
Research and Diagnostic Systems	PTE4X	FDA UDI	Class II	Active
Research and Diagnostic Systems	4R002	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC234L	FDA UDI	Class II	Active
Research and Diagnostic Systems	CL001	FDA UDI	Class II	Active
Research and Diagnostic Systems	GH00L	FDA UDI	Class II	Active
Research and Diagnostic Systems	ST405	FDA UDI	Class II	Active
Research and Diagnostic Systems	8CD02	FDA UDI	Class II	Active
Research and Diagnostic Systems	BFI002	EUDAMEDFDA UDI	Class II	Active
Research and Diagnostic Systems	D3D02	EUDAMEDFDA UDI	Class II	Active
Research and Diagnostic Systems	DTFR1	FDA UDI	Class II	Active
Research and Diagnostic Systems	PTE3X	FDA UDI	Class II	Active
Research and Diagnostic Systems	FC237	FDA UDI	Class II	Active
Research and Diagnostic Systems	SR00TS	FDA UDI	Class II	Active
Research and Diagnostic Systems	3K301	FDA UDI	Class II	Active

RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

What RESEARCH AND DIAGNOSTIC SYSTEMS, INC. makes

Frequently asked questions

Information

Catalogue (183)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities