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Sure-Tech Diagnostic Associates, Inc.

Country not established FDA establishment FEI 1938095

Devices
13
Registrations
FDA
FDA recalls
0

What Sure-Tech Diagnostic Associates, Inc. makes

Sure-Tech Diagnostic Associates, Inc. makes fetal hemoglobin testing devices.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

FDA FEI number
1938095
Address
12115 Tesson Ferry Professional Ctr, Saint Louis, MO, 63128

Frequently asked questions

How many devices does SURE-TECH DIAGNOSTIC ASSOCIATES, INC. have in the registry?

The registry currently lists 13 devices for SURE-TECH DIAGNOSTIC ASSOCIATES, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list SURE-TECH DIAGNOSTIC ASSOCIATES, INC.'s devices?

Among its 13 most recently registered devices, SURE-TECH DIAGNOSTIC ASSOCIATES, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SURE-TECH DIAGNOSTIC ASSOCIATES, INC.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for SURE-TECH DIAGNOSTIC ASSOCIATES, INC.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from SURE-TECH DIAGNOSTIC ASSOCIATES, INC. in the registry?

The most recently registered devices listed for SURE-TECH DIAGNOSTIC ASSOCIATES, INC. include ST 201 Fetal Hemoglobin Control, ST 201-B Fetal Hemoglobin Control, ST 201-C Fetal Hemoglobin Control and Fetal Hemoglobin Kit - 100 test kit ST 101-A.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.