Provalis Diagnostics, Ltd.
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Provalis Diagnostics, Ltd. makes
Provalis Diagnostics, Ltd. manufactures in vitro diagnostic devices for measuring hemoglobin A1c levels, including the Glycosal HBA1C Test, Glycosal II HBA1C Test, and the G5 I and G5 II HBA1C Tests. These products are designed for monitoring long-term blood glucose levels in patients with diabetes.
The company’s portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in clinical settings to support diabetes management.
Catalogue
Glycosal HBA1C Test Ref K001392
Regimes: 510(k) Registry: 510(k)Glycosal Ii Hba 1C Test Ref K011933
Regimes: 510(k) Registry: 510(k)G5 I HBA1C Test, G5 Ii HBA1C Test Ref K041635
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Provalis Diagnostics, Ltd., initiated on 2005-05-20. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 20 May 2005 Z-0171-06 Unclassified (pre-2012) Terminated Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.
Frequently asked questions
How many devices does Provalis Diagnostics, Ltd. have in the registry?
The registry currently lists 3 devices for Provalis Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Provalis Diagnostics, Ltd.'s devices?
Among its 3 most recently registered devices, Provalis Diagnostics, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Provalis Diagnostics, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Provalis Diagnostics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Provalis Diagnostics, Ltd.?
FDA recall records list 1 recall initiated by Provalis Diagnostics, Ltd., the most recent initiated on 20 May 2005. 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 Provalis Diagnostics, Ltd. in the registry?
The most recently registered devices listed for Provalis Diagnostics, Ltd. include GLYCOSAL HBA1C TEST, GLYCOSAL II HBA 1C TEST and G5 I HBA1C TEST, G5 II HBA1C TEST.