In Vitro Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What In Vitro Diagnostics, Inc. makes
The company manufactures in vitro diagnostic reagents and standards, including enzyme immunoassay kits for thyroid hormones (TSH, T4, FSH, LH), digoxin, and uptake assays, as well as flame photometer standards and lithium/cesium diluents for laboratory use.
These products are regulated under FDA’s Class I and Class II device classifications and are listed via the 510(k) pathway in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does In Vitro Diagnostics, Inc. have in the registry?
The registry currently lists 15 devices for In Vitro Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list In Vitro Diagnostics, Inc.'s devices?
Among its 15 most recently registered devices, In Vitro Diagnostics, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do In Vitro Diagnostics, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for In Vitro Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from In Vitro Diagnostics, Inc. in the registry?
The most recently registered devices listed for In Vitro Diagnostics, Inc. include T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT, LITHIUM INTERNAL STANDARD 1 MEQ/L #60085, VITRO T4-EIA-XT and FLAME PHOTOMETER STANDARD #60083 160 NA/8K.