Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards)

Basic Information

• Brand Name: Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards)
• Primary DI: 00857275007131
• Version / Model: IDOA-755-5P
• Company Name: IDUN SOLUTIONS LLC
• Labeler DUNS: 080651010
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-16
• Public Version: 7
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 491fb626-5584-4925-bad5-4de080d5c8d6
• Distribution End Date: 2022-01-01

Device Description

5 tests kit; 5-Panel Dip Cards; AMP/BZO/COC/OPI/THC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: Yes
• 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
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	862.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30519	Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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
30520	Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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
30518	Benzodiazepine group 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 benzodiazepine 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
30516	Amphetamine-specific 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 a specific amphetamine 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
55701	Morphine/morphine metabolite 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 morphine and/or morphine metabolites 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	00857275007131	GS1
Package	00857275007032	GS1		5	Not in Commercial Distribution	2022-01-01

Premarket Submissions

Submission Number	Supplement Number
K153050	000