ImmuTest Drugs of Abuse Screen Card

Basic Information

• Brand Name: ImmuTest Drugs of Abuse Screen Card
• Primary DI: 00816565020113
• Version / Model: IMDA-5M
• Catalog Number: IMDA-5M
• Company Name: AMEDITECH INC.
• Labeler DUNS: 010551716
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 7
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: bf27344b-b15a-4fe2-8769-cdf13ee0c9a9
• Distribution End Date: 2018-06-01

Device Description

AMP/COC/MET1000/OPI2000/THC multiple drugs dipcard with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	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	00816565020113	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113046	000

Storage Conditions

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