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r2 Diagnostics Inc.

United States US-MF-000020735 Last updated 8 Jun 2026

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Devices
14
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue14

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • R2 Diagnostics, Inc. SOUTH BEND, IN · US FEI 3000210416

About

r² Diagnostics, a sister company of Enzyme Research Laboratories (ERL), was incorporated in 1993 as an FDA 21CFR820 registered and an ISO 13485 certified manufacturer and distributer of hemostasis products for the clinical coagulation laboratory.

From the manufacturer's own website. Source

What r2 Diagnostics Inc. makes

r2 Diagnostics Inc. manufactures in vitro diagnostic (IVD) products for coagulation testing, including emicizumab controls and calibrators used to standardize laboratory measurements.

These products fall under IVD General device classification and are listed in the EU’s eudamed registry. The company 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 r2 Diagnostics Inc. manufacture?

r2 Diagnostics Inc. specializes in in vitro diagnostic (IVD) products specifically for coagulation testing. Their devices include emicizumab controls and calibrators, which are used in clinical laboratories to ensure accurate and standardized measurements of blood clotting factors. These products help maintain consistency in diagnostic testing for conditions related to hemostasis.

Where is r2 Diagnostics Inc. based?

r2 Diagnostics Inc. is headquartered in the United States. The company operates within the regulatory framework of the FDA and aligns its products with international standards, including those applicable in the EU.

Which regulatory registries list devices manufactured by r2 Diagnostics Inc.?

Devices produced by r2 Diagnostics Inc. are listed in the EU’s eudamed registry. This registry is used to track in vitro diagnostic medical devices authorized for commercialization within the European Economic Area, ensuring transparency and traceability of these products.

How are the devices manufactured by r2 Diagnostics Inc. classified?

The devices manufactured by r2 Diagnostics Inc., such as emicizumab controls and calibrators, fall under the IVD General classification. This classification applies to in vitro diagnostic devices that are not classified as high-risk or specialized, ensuring they meet general regulatory requirements for safety and performance in clinical settings.

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

Information

Country
United States
Address
1801, COMMERCE DR, SOUTH BEND, United States
Phone
+15742884377
PRRC contact
Erick Nieves
EUDAMED SRN
US-MF-000020735