In Vitro Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What In Vitro Technologies, Inc. makes
In Vitro Technologies, Inc. manufactures in vitro diagnostic devices for allergen-specific immunoglobulin E (IgE) testing, including allergen screens and radioallergosorbent assay (RAST) tracer systems. These products are designed to identify specific allergens in patient serum samples, supporting the diagnosis of allergic conditions such as asthma, hay fever, and food allergies. The portfolio includes regional allergy screens (Central, Northeast, Southeast, Southwest) and a RAST tracer system for quantitative allergen measurement.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Ivt Central Allergy Screen Ref K875329
Regimes: 510(k) Registry: 510(k)Ivt Western Allergy Screen Ref K875328
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ivt Rast Tracer Ref K904661
Regimes: 510(k) Registry: 510(k)Ivt Northeast Allergy Screen Ref K874169
Regimes: 510(k) Registry: 510(k)Ivt Southeast Allergy Screen Ref K874168
Regimes: 510(k) Registry: 510(k)Ivt Southwest Allergy Screen Ref K870625
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does In Vitro Technologies, Inc. have in the registry?
The registry currently lists 7 devices for In Vitro Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list In Vitro Technologies, Inc.'s devices?
Among its 7 most recently registered devices, In Vitro Technologies, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do In Vitro Technologies, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for In Vitro Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from In Vitro Technologies, Inc. in the registry?
The most recently registered devices listed for In Vitro Technologies, Inc. include IVT CENTRAL ALLERGY SCREEN, IVT WESTERN ALLERGY SCREEN, 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS and IVT RAST TRACER.