Branan Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 160
- FDA recalls
- 2
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 devices- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect Ii Mdma Drug Screen Dipstick Test, Model MF22 Ref K040203
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Showing 151-160 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.