Branan Medical Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 160
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Branan Medical Corp. makes
Branan Medical Corp. manufactures rapid drug screening devices, including dipcards, dipsticks, test cups, and cassette tests for detecting substances such as cocaine, methamphetamine, THC, PCP, oxycodone, MDMA, and barbiturates. Their products are designed for point-of-care use in clinical, forensic, and workplace settings to identify drug presence in urine or other samples. The portfolio also includes modified test cups for adulteration detection and specialized screening for specific compounds like tricyclic antidepressants (TCA).
The company’s devices are classified under FDA’s Class II and Unclassified (U) categories, with regulatory submissions recorded in the FDA’s 510(k) database. Products are intended for use in the United States, where compliance with FDA requirements applies. No additional registries or international listings are indicated.
Catalogue
Search and filter all 160 devicesShowing 1-50 of 160
FDA recalls
FDA recall records list 2 recalls initiated by Branan Medical Corp., the earliest on 2014-03-26 and the most recent on 2016-07-05. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 5 Jul 2016 Z-2311-2016 Class III Terminated Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.
2014
- 26 Mar 2014 Z-1508-2014 Class II Terminated May be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Frequently asked questions
How many devices does Branan Medical Corp. have in the registry?
The registry currently lists 160 devices for Branan Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Branan Medical Corp.'s devices?
Among its 50 most recently registered devices, Branan Medical Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do Branan Medical Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Branan Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Branan Medical Corp.?
FDA recall records list 2 recalls initiated by Branan Medical Corp., the most recent initiated on 2016-07-05. 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 Branan Medical Corp. in the registry?
The most recently registered devices listed for Branan Medical Corp. include AmediCheck Instant Test Cup C-C0503A-3A, ToxCup Drug Screen Cup PT13, ToxCup Drug Screen Cup PT15 and Fastect II Drug Screen Dipstick Test MF19.