Diagnostic Specialties
Country not established
- Devices
- 8
What Diagnostic Specialties makes
Diagnostic Specialties manufactures in-vitro diagnostic (IVD) reagents and test kits for clinical laboratory use, including pregnancy tests, potassium reagent sets, protein-bound glucose assay kits, glucose enzyme-color reagent sets, and immunoturbidimetric assay kits for microalbumin and fibrinogen. These products are designed for quantitative and qualitative analysis in urine and serum samples, supporting diagnostic testing for conditions such as pregnancy, kidney function, and metabolic disorders.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The manufacturer operates from the US.
Catalogue
Pregna-Cert, Slide Pregnancy Test Ref K831180
510(k) 510(k)Potassium Reagent Set Ref K813608
510(k) 510(k)Protein-Bound Glucose Assayn Kit Ref K930823
510(k) 510(k)Glucose Enzyme-Color Reagent Set Ref K813412
510(k) 510(k)Enzip Urinary Microalbumin Test Ref K922032
510(k) 510(k)Enzip Immunoturbidimetric Microalbumin Assay Kit Ref K971458
510(k) 510(k)Generic Pregnancy Test Ref K823109
510(k) 510(k)Enzip Immunoturbidmetric Fibrinogen Assay Kit Ref K941001
510(k) 510(k)
Frequently asked questions
How many devices does Diagnostic Specialties have in the registry?
The registry currently lists 8 devices for Diagnostic Specialties. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostic Specialties's devices?
Among its 8 most recently registered devices, Diagnostic Specialties has devices listed in FDA 510(k) (8 devices).
What risk classes do Diagnostic Specialties's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Diagnostic Specialties's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnostic Specialties in the registry?
The most recently registered devices listed for Diagnostic Specialties include PREGNA-CERT, SLIDE PREGNANCY TEST, POTASSIUM REAGENT SET, PROTEIN-BOUND GLUCOSE ASSAYN KIT and GLUCOSE ENZYME-COLOR REAGENT SET.