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US
Last updated May 23, 2026
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.
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 Sterling Diagnostics Inc manufacture?
Sterling Diagnostics Inc specializes in in vitro diagnostic (IVD) reagents used primarily in laboratory settings. Their products include reagents for testing total cholesterol, urea, total bilirubin, alkaline phosphatase isoenzyme, gamma-hydroxybutyrate (GHB), glucose, creatinine, haemoglobin S (HbS), and enzymatic assays for potassium, uric acid, sodium, iron, and serum proteins. These reagents are designed to support clinical chemistry and haematology testing.
Where is Sterling Diagnostics Inc based, and how does that affect its regulatory oversight?
Sterling Diagnostics Inc is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since their products are IVD reagents, they are classified under FDA regulations, with most falling into Class I or Class II categories, depending on their risk level and intended use.
Which regulatory registries list Sterling Diagnostics Inc’s devices?
Sterling Diagnostics Inc’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. regulatory requirements for IVD reagents, providing transparency on their authorised products and classifications.
How are Sterling Diagnostics Inc’s devices classified by the FDA?
The FDA classifies Sterling Diagnostics Inc’s IVD reagents primarily as Class I or Class II devices. Class I devices generally pose minimal risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the nature of the testing performed.
What does it mean for a Sterling Diagnostics Inc device to be listed in the FDA’s 510(k) registry?
Listing in the FDA’s 510(k) registry indicates that the manufacturer has submitted a premarket notification to demonstrate that their IVD reagent is substantially equivalent to a legally marketed predicate device. This process ensures that the device meets FDA safety and performance standards before being authorised for commercial distribution in the U.S. market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 155284151
Catalogue (65)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Potassium | 2238-0 | FDA UDI | N/A | Active |
| Enzymatic Uric Acid | 2305-0 | FDA UDI | N/A | Active |
| Super Sensitive Cholesterol | 2147-0 | FDA UDI | N/A | Active |
| T. Protein Rgt Set | 2240-0 | FDA UDI | N/A | Active |
| Sodium Kit | 2266-0 | FDA UDI | N/A | Active |
| Serum Iron/Ibc | 2200-0 | FDA UDI | N/A | Active |
| Enzymatic Cholesterol | 2145-L | FDA UDI | N/A | Active |
| Urea Nitrogen (berthelot) | 2290-0 | FDA UDI | N/A | Active |
| Enzymatic Glucose | 2185-L | FDA UDI | N/A | Active |
| Sgot Colorimetric | 2250-0 | FDA UDI | N/A | Active |
| Hdl Cholesterol | 2150-P | FDA UDI | N/A | Active |
| Albumin Rgt Set | 2110-0 | FDA UDI | N/A | Active |
| Cpk / Colorimetric | 2155-0 | FDA UDI | N/A | Active |
| Glycohemoglobin | 2193-0 | FDA UDI | N/A | Active |
| Alkaline Phosphatase | 2115-0 | FDA UDI | N/A | Active |
| SGPT Colorimetric | 2260-0 | FDA UDI | N/A | Active |
| Rpr Card Test | S168-0 | FDA UDI | N/A | Active |
| Sickle Cell | 2243-0 | FDA UDI | N/A | Active |
| Total Bilirubin | 2135-0 | FDA UDI | N/A | Active |
| Triglycerides - Gpo | 2285-0 | FDA UDI | N/A | Active |
| Enzymatic Cholesterol | 2145-0 | FDA UDI | N/A | Active |
| Urea Nitrogen (berthelot) | 2290-L | FDA UDI | N/A | Active |
| Total And Direct Bilirubin | 2130-0 | FDA UDI | N/A | Active |
| Creatinine/ Endpoint | 2167-0 | FDA UDI | N/A | Active |
| Alkaline Phosphatase Reagent Set | K860351 | FDA 510(k) | Class II | Active |
| Inorganic Phosphorus Reagent Set | K860628 | FDA 510(k) | Class I | Active |
| Phospholipid Reagent Set | K914040 | FDA 510(k) | Class I | Active |
| Uric Acid Reagnet Set (trinder) | K860477 | FDA 510(k) | Class I | Active |
| Urea Nitrogen (gldh) Reagent Set (uv) | K862210 | FDA 510(k) | Class II | Active |
| Serum Albumin (bcg) Reagent Set | K860340 | FDA 510(k) | Class II | Active |
| Serum Potassium Reagent Set | K861713 | FDA 510(k) | Class II | Active |
| Creatinine Reagent Set | K860418 | FDA 510(k) | Class II | Active |
| Alt (sgpt) Reagent Set (uv Rate) | K862209 | FDA 510(k) | Class I | Active |
| Sgpt (alt) Reagent Set (colorimetric) | K860485 | FDA 510(k) | Class I | Active |
| Serum Lipase Reagent Set (turbidimetric) | K860554 | FDA 510(k) | Class I | Active |
| Total Protein (biuret) Reagent Set | K860341 | FDA 510(k) | Class II | Active |
| Hemoglobin Reagent Set | K860475 | FDA 510(k) | Class II | Active |
| Urea Nitrogen Reagent Set | K860419 | FDA 510(k) | Class II | Active |
| Acid Phosphatase Reagent Set | K860476 | FDA 510(k) | Class II | Active |
| Cpk Reagent Set (colorimetric) | K860096 | FDA 510(k) | Class II | Active |
| Serum Cholinesterase Reagent Set | K860350 | FDA 510(k) | Class I | Active |
| Aspartate Aminotransferase (ast/Sgot) Reagent Set | K860667 | FDA 510(k) | Class II | Active |
| Microprotein Reagent Set | K921412 | FDA 510(k) | Class II | Active |
| Triglycerides Reagent Set | K914609 | FDA 510(k) | Class I | Active |
| Amylase Reagent Set (modified Caraway) | K860530 | FDA 510(k) | Class II | Active |
| Gamma Glutamyl Transpeptidase (ggtp) Reagent Set | K860348 | FDA 510(k) | Class I | Active |
| Sickle Cell Reagent Set | K860420 | FDA 510(k) | Class II | Active |
| Uric Acid Reagent Set (colorimetric) | K860142 | FDA 510(k) | Class I | Active |
| Enzynatic Triglycerides Reagent Set | K855164 | FDA 510(k) | Class I | Active |
| Salicylate Reagent Set | K861615 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Sterling Diagnostics Inc. has one recall record initiated on July 20, 2016, involving multiple diagnostic kits. The recall was due to a revision of previously extended expiration dates. The status of the recall is recorded as terminated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 20, 2016 | Z-0932-2017 | — | 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. |
| Jul 20, 2016 | Z-0937-2017 | — | 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. |
| Jul 20, 2016 | Z-0929-2017 | — | 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. |
| Jul 20, 2016 | Z-0934-2017 | — | 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. |
| Jul 20, 2016 | Z-0936-2017 | — | 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. |
| Jul 20, 2016 | Z-0935-2017 | — | 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. |
| Jul 20, 2016 | Z-0931-2017 | — | 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. |
| Jul 20, 2016 | Z-0930-2017 | — | 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. |
| Jul 20, 2016 | Z-0933-2017 | — | 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. |