Data / Medical devices / United States / Premier Biotech, LLC

Premier Biotech, LLC: FDA-registered device maker in Minneapolis, MN, United States, 3 510(k) clearances

Name: Premier Biotech, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Premier Biotech, LLC is registered with the FDA (registration 3010800486) in Minneapolis, MN, United States. It lists 23 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 20, 2018. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Premier Biotech, LLC

FDA registration number: 3010800486
Address: 725 Kasota Ave SE, Minneapolis, MN, United States, 55414
Owner or operator: Premier Biotech, LLC (10057135)
Roles: Complaint file establishment, Manufacturer for export, Specification developer
First device listed: March 9, 2018
Registered through: 2026
Brand names listed: O-Swab, OT-Scan, OralTox, OralTox Oral Fluid Drug Test, OralToxWP, Premier Bio-Cup, Premier Bio-Dip, Premier OralTox

Devices it lists

Device	Product code	Class	Role	Source
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	JQT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Complaint file establishment	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, Exempt	PUX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, Exempt	PUY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Codeine, Employment And Insurance Testing, Exempt	PVB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, Exempt	PVE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, Exempt	PVG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 20, 2018	K181305	OralTox Oral fluid Drug Test	DJC	Substantially Equivalent	Premier Biotech, Inc.	accessdata.fda.gov
February 2, 2018	K171403	OralTox Oral Fluid Drug Test	DJC	Substantially Equivalent	Premier Biotech, Inc.	accessdata.fda.gov
June 17, 2013	K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	DKZ	Substantially Equivalent	Advin Biotech	accessdata.fda.gov

Compare with other makers

Updated September 20, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.