Diagnostica, Inc.
US Last updated 23 May 2026
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- Devices
- 12
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
H. Influenza B Antisera For Cie Ref K823348
Ease-A-Cult Ref K002756
Buffer, Collagen Reagent And Diluent Ref K781710
Anti-Human Igg Serum Ref K791281
Anti-Human Kappa Serum Ref K791284
Diagnostic Kits & Kit Components Ref K812434
Aspergillus Fumigatus, Aspergillus Flavu Ref K790672
Anti-Human Serum Ref K791282
Anti-Human Globulins Ref K791285
Paracontrol Abnormal Immunoglobulin Cont Ref K800398
Dermatophytin O Ref K790671
Anti-Human Lambda Serum Ref K791283
FDA establishments
- Diagnostica AS NO
What Diagnostica, Inc. makes
Diagnostica, Inc. manufactures serological reagents, antisera, and diagnostic kits for laboratory testing, including antisera for influenza B, human immunoglobulins (IgG, kappa, lambda), and fungal antigens like *Aspergillus fumigatus*. Their portfolio also includes collagen buffers, diluents, and specialized control reagents for immunology and microbiology assays, such as *Dermatophytin O* and *Paracontrol* abnormal immunoglobulin controls.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. Their reagents and diagnostic components are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does Diagnostica, Inc. manufacture?
Diagnostica, Inc. specializes in serological reagents, antisera, and diagnostic kits primarily used in laboratory testing. Their products include antisera for detecting diseases like influenza B, human immunoglobulin components (such as IgG, kappa, and lambda), fungal antigen reagents like *Aspergillus fumigatus*, and specialized controls for immunology and microbiology assays. These items are designed to support diagnostic procedures in clinical and research settings.
Where is Diagnostica, Inc. based, and how does that affect its regulatory standing?
Diagnostica, Inc. is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations. The company’s products fall under FDA classifications of Class I and Class II, which determine the regulatory pathway for clearance or exemption. Many of their devices are cleared via the 510(k) process, a premarket submission pathway for demonstrating substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Diagnostica, Inc.’s devices?
Diagnostica, Inc.’s devices are listed in the FDA’s 510(k) database. This registry includes products that have undergone the 510(k) clearance process, demonstrating compliance with U.S. medical device regulations. Listing in this database confirms that the manufacturer’s devices meet FDA requirements for safety and effectiveness, though it does not imply company-wide approval—only that individual devices have been authorized through the specified pathway.
How are Diagnostica, Inc.’s devices classified under FDA regulations?
Diagnostica, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may be exempt from premarket notification (510(k)) requirements, while Class II devices require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization, with many of Diagnostica’s products cleared via the 510(k) process, which involves demonstrating equivalence to a previously cleared device. This classification ensures appropriate oversight based on the device’s risk level.
Information
- Country
- US