American Diagnostica, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Acticlot, Model 824 Ref K052124
Regimes: 510(k) Registry: 510(k)Dimertest Ref K080069
Regimes: 510(k) Registry: 510(k)Actichrome Heparin (Anti-Fxa), Model 832 Ref K013318
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Spectrolyse Pai-1, Model 101201 Ref K063323
Regimes: 510(k) Registry: 510(k)Imubind Tpa Elisa, Model 860 Ref K013492
Regimes: 510(k) Registry: 510(k)Dv Test And Dvv Confirm Ref K940490
Regimes: 510(k) Registry: 510(k)Actichrome Heparin (Anti-Fiia) Ref K013637
Regimes: 510(k) Registry: 510(k)Acticlot Protein S, Model 843l Ref K012386
Regimes: 510(k) Registry: 510(k)Imubind Plasma Pai-1 Elisa, Model 822 Ref K013168
Regimes: 510(k) Registry: 510(k)
FDA recalls
2010
- 5 Mar 2010 Z-1426-2010 Unclassified (pre-2012) Terminated Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
2007
- 28 Feb 2007 Z-0779-2007 Unclassified (pre-2012) Terminated Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
Frequently asked questions
How many devices does American Diagnostica, Inc. have in the registry?
The registry currently lists 10 devices for American Diagnostica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Diagnostica, Inc.'s devices?
Among its 10 most recently registered devices, American Diagnostica, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do American Diagnostica, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for American Diagnostica, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for American Diagnostica, Inc.?
FDA recall records list 2 recalls initiated by American Diagnostica, Inc., the most recent initiated on 5 Mar 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from American Diagnostica, Inc. in the registry?
The most recently registered devices listed for American Diagnostica, Inc. include ACTICLOT, MODEL 824, DIMERTEST, ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 and DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA.