Identify Diagnostics USA

Basic Information

• Brand Name: Identify Diagnostics USA
• Primary DI: 10850721007898
• Version / Model: ID-US10-DIP-1
• Catalog Number: ID-US10-DIP-1
• Company Name: MEDICAL DISTRIBUTION GROUP INC
• Labeler DUNS: 064177324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-04-18
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: bc6b232c-9cf0-4c68-bc60-8b776e39a42b
• Distribution End Date: 2030-04-18

Device Description

Identify Diagnostics USA Drug Test Dip Card - AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
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
Package	20850721007895	GS1	CASE	8	In Commercial Distribution	2030-04-18
Primary	10850721007898	GS1
Unit of Use	00850721007891	GS1

Premarket Submissions

Submission Number	Supplement Number
K122809	000

Storage Conditions

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