Intl. Diagnostic, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Intl. Diagnostic, Inc. makes
Intl. Diagnostic, Inc. manufactures rapid diagnostic tests for pregnancy and inflammatory markers, including lateral flow and tube-based assays for human chorionic gonadotropin (hCG) and C-reactive protein (CRP). Their products also include over-the-counter pregnancy test kits designed for home use.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
Nabi Crp-Q.S. Test Ref K834584
Regimes: 510(k) Registry: 510(k)Pregnancy Test Kit, Over-The-Counter Ref K780321
Regimes: 510(k) Registry: 510(k)Preg-Beta One Hour Tube Test Ref K841853
Regimes: 510(k) Registry: 510(k)Nabi Rf-Q.S. Test Ref K840005
Regimes: 510(k) Registry: 510(k)Pregna B-Anti Human Chorionic Gonadotro Ref K802343
Regimes: 510(k) Registry: 510(k)Preg Beta Blus Slide Ref K840833
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intl. Diagnostic, Inc. have in the registry?
The registry currently lists 6 devices for Intl. Diagnostic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intl. Diagnostic, Inc.'s devices?
Among its 6 most recently registered devices, Intl. Diagnostic, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Intl. Diagnostic, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Intl. Diagnostic, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intl. Diagnostic, Inc. in the registry?
The most recently registered devices listed for Intl. Diagnostic, Inc. include NABI CRP-Q.S. TEST, PREGNANCY TEST KIT, OVER-THE-COUNTER, PREG-BETA ONE HOUR TUBE TEST and NABI RF-Q.S. TEST.