Elan Diagnostics
Country not established
- Devices
- 13
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Elan Diagnostics makes
Elan Diagnostics makes reagents and calibrators for various medical tests, including calcium, albumin, LDL, BUN, phosphorus, HDL cholesterol, glucose, magnesium, total bilirubin, direct bilirubin, and creatinine tests.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) registry. Elan Diagnostics is based in the US.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 1 recall initiated by Elan Diagnostics, initiated on 2002-11-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 7 Nov 2002 Z-0404-03 Unclassified (pre-2012) Terminated Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery
Frequently asked questions
How many devices does Elan Diagnostics have in the registry?
The registry currently lists 13 devices for Elan Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elan Diagnostics's devices?
Among its 13 most recently registered devices, Elan Diagnostics has devices listed in FDA 510(k) (13 devices).
What risk classes do Elan Diagnostics's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Elan Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Elan Diagnostics?
FDA recall records list 1 recall initiated by Elan Diagnostics, the most recent initiated on 2002-11-07. 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 Elan Diagnostics in the registry?
The most recently registered devices listed for Elan Diagnostics include ATAC CALCIUM REAGENT AND ATAC CALIBRATOR, ATAC CALIBRATOR, ATAC PAK ALBUMIN REAGENT and ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS.