Sterling Diagnostics Inc
United StatesFDA applicant, unverified
Sterling Diagnostics Inc is a medical device manufacturer, with 65 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) and 9 FDA recalls as of 14 Nov 2026.
- Devices
- 65
- FDA recalls
- 9
Registry facts
- Registries
- FDA 510(k) 41
- FDA GUDID 24
- Device classes
- FDA Class II 25
- FDA Class I 16
- FDA recalls
- Identifiers
- DUNS 155284151
At a glance
Market reach
- United States
- FDA recalls
What Sterling Diagnostics Inc makes
Sterling Diagnostics Inc manufactures in vitro diagnostic (IVD) reagents for laboratory testing, including assays for total cholesterol, urea, total bilirubin, alkaline phosphatase isoenzyme, gamma-hydroxybutyrate (GHB), glucose, creatinine, and haemoglobin S (HbS). Their portfolio also covers enzymatic tests for potassium, uric acid, sodium, iron, and serum proteins, as well as colorimetric and enzymatic glucose measurements.
The company’s products are regulated under FDA classifications, with most falling into Class I and Class II devices. These reagents are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, ensuring compliance with US regulatory requirements. The manufacturer operates from the United States.
Catalogue
Search and filter all 65 devicesShowing 1-50 of 65
Company details
- DUNS number
- 155284151
FDA recalls
FDA recall records list 9 recalls initiated by STERLING DIAGNOSTICS INC, initiated on 2016-07-20. By recorded status: 9 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 20 Jul 2016 Z-0929-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0930-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0931-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0932-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0933-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0934-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0935-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0936-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- 20 Jul 2016 Z-0937-2017 Class III Terminated Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Frequently asked questions
How many devices does STERLING DIAGNOSTICS INC have in the registry?
The registry currently lists 65 devices for STERLING DIAGNOSTICS INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list STERLING DIAGNOSTICS INC's devices?
Among its 50 most recently registered devices, STERLING DIAGNOSTICS INC has devices listed in FDA 510(k) (26 devices) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do STERLING DIAGNOSTICS INC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for STERLING DIAGNOSTICS INC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for STERLING DIAGNOSTICS INC?
FDA recall records list 9 recalls initiated by STERLING DIAGNOSTICS INC, the most recent initiated on 20 Jul 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from STERLING DIAGNOSTICS INC in the registry?
The most recently registered devices listed for STERLING DIAGNOSTICS INC include POTASSIUM 2238-0, ENZYMATIC URIC ACID 2305-0, SUPER SENSITIVE CHOLESTEROL 2147-0 and T. PROTEIN RGT SET 2240-0.