OralTox

GUDID B313OT805091

5 Panel OralTox Device - COC/MET/OPI/OXY/THC

PREMIER BIOTECH, INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device IDB313OT805091
NIH Device Record Key4cd9a0eb-a3f3-49bb-a465-08d7763e7f51
Commercial Distribution Discontinuation2020-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameOralTox
Version Model NumberOT80509
Company DUNS010118759
Company NamePREMIER BIOTECH, INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB313OT805090 [Unit of Use]
HIBCCB313OT805091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

On-Brand Devices [OralTox]

B313OT8080718 Panel OralTox - AMP/COC/MET/MTD/OPI/OXY/PCP/THC
B313OT8070117 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
B313OT806221OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
B313OT8060516 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
B313OT8060216 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
B313OT8051015 Panel OralTox - COC/MET/OPI/OXY/THC
B313OT8050915 Panel OralTox Device - COC/MET/OPI/OXY/THC
B313OT8050815 Panel OralTox - AMP/COC/MET/OPI/THC
B313OT8050415 Panel OralTox - AMP/COC/OPI/PCP/THC
B313OT8050215 Panel OralTox - AMP/COC/MET/OPI/THC
B313OT8040414 Panel OralTox - AMP/COC/OPI/PCP
B313OT8040214 Panel OralTox - COC/MET/OPI/OXY
B313OT8040114 Panel OralTox - AMP/COC/OPI/THC

Trademark Results [OralTox]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORALTOX
ORALTOX
85759600 4393988 Live/Registered
Premier Biotech
2012-10-22

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