Premier Biotech, LLC

FDA Device Registration & Listing · Minneapolis, MN, US · Registration 3010800486

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010800486
FEI Number
3010800486
Entity Name
Premier Biotech, LLC
City/State/Country
Minneapolis, MN, US
Establishment Address
725 Kasota Ave SE, Minneapolis, MN 55414, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Premier Biotech, LLC (Owner Number: 10057135)
Owner / Operator Contact Address
725 Kasota Avenue SE, Minneapolis, MN 55414, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OralTox Oral Fluid Drug Test OralTox Oral Fluid Drug Test Premier OralTox Premier OralTox OralTox O-Swab Premier OralTox OralTox O-Swab Premier OralTox OralTox O-Swab Premier OralTox OralToxWP O-Swab OralToxWP O-Swab OralToxWP O-Swab OralTox O-Swab OralTox O-Swab OT-Scan OralTox O-Swab Premier OralTox OralTox O-Swab

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-03-09
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-03-09
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-03-09
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-03-09
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-03-09
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-03-09
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2018-09-24
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-09-24
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2018-09-24
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2018-09-24
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-09-24
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2018-09-24
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2018-09-24
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2024-07-11
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2024-07-11
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2021-09-10
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-07-11
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2021-09-10
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2024-07-11
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2021-09-10
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2024-07-11
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2021-09-10
PVB Test, Codeine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3270 2021-09-10
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2021-09-10
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2021-09-10
MRS Test System, Nicotine, Cotinine, Metabolites Clinical Toxicology Class 1 862.3220 2020-11-03
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2021-09-16
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2021-09-10
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-07-11
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2021-09-10

Official Correspondent

Matthew Michalik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Premier Biotech, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K132630 Guangzhou Wondfo Biotech Co., Ltd. WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) 2013-09-27
K970265 Drial Consultants, Inc. ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST 1997-04-08
K051161 Quest Diagnostics, Inc. QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) 2005-11-22
K122904 Guangzhou Wondfo Biotech Co., Ltd. WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; 2012-11-15
K121987 Guangzhou Wondfo Biotech Co., Ltd. WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST 2012-08-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010800486. Last updated year: 2026. Please use registration number 3010800486 when referencing this establishment in official correspondence.
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