Azer Scientific, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3009963993
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 2
What Azer Scientific, Inc. makes
Azer Scientific, Inc. manufactures the Azer Scientific Universal Transport Medium, a sterile, non-nutrient medium used for transporting clinical specimens, such as swabs, to a laboratory for microbiological analysis.
The company’s product is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Azer Scientific Universal Transport Medium Ref K202531
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009963993
- Address
- 701 Hemlock Rd, Morgantown, PA, 19543
FDA recalls
FDA recall records list 2 recalls initiated by AZER SCIENTIFIC, INC., initiated on 2016-08-24. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and 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.
2016
- 24 Aug 2016 Z-0329-2017 Class II Terminated Out of Specification Microbiological test results
- 24 Aug 2016 Z-0330-2017 Class II Terminated Out of Specification Microbiological test results
Frequently asked questions
How many devices does AZER SCIENTIFIC, INC. have in the registry?
The registry currently lists 1 device for AZER SCIENTIFIC, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list AZER SCIENTIFIC, INC.'s devices?
Among its 1 most recently registered device, AZER SCIENTIFIC, INC. has devices listed in FDA 510(k) (1 device).
What risk classes do AZER SCIENTIFIC, INC.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for AZER SCIENTIFIC, INC.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for AZER SCIENTIFIC, INC.?
FDA recall records list 2 recalls initiated by AZER SCIENTIFIC, INC., the most recent initiated on 24 Aug 2016. 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 AZER SCIENTIFIC, INC. in the registry?
The most recently registered devices listed for AZER SCIENTIFIC, INC. include Azer Scientific Universal Transport Medium.