Premier Bio-Cup & Bio-Dip

Basic Information

• Brand Name: Premier Bio-Cup & Bio-Dip
• Primary DI: B313PBCARD10331
• Version / Model: PBCard-10-33
• Catalog Number: PBCard-10-33
• Company Name: PREMIER BIOTECH, INC
• Labeler DUNS: 010118759
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2017-09-25
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: fc699a25-104d-41f5-9c5a-510bba601316
• Distribution End Date: 2080-01-01

Device Description

AMP500/BAR300/BZO300/COC150/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B313PBCARD10331	HIBCC
Unit of Use	B313PBCARD10330	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K122809	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius