Device
Identify Health, 14 Panel Drug Screen Test Cup, CLIA Waived
Manufacturer
MEDICAL DISTRIBUTION GROUP INC
Model: ID-H14-ADULT-1-AZ1 Catalog: ID-H14-ADULT-1-AZ1 DI: 10850013035585 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-21 Current Version: 2026-05-29 Distribution End: 2046-05-21
Description
Identify Health, 14 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BAR300, BUP10, BZO300, COC150, EDDP300, MDMA500, MET500, MTD300, OPI300, OXY100, PCP25, TCA1000, THC50) + (SG, pH, OX) + (CR,Nl,GL) Contents: Test Cups - 1, Package Insert - 1, Adulteration Card - 1, Security Seals - 1, For In Vitro Diagnostics Use
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: da2440d4-5906-4c10-a8e7-7b6a2e5a7cdd
Distribution Status: In Commercial Distribution
DUNS Number: 064177324
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 10850013035585
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46994
Name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Definition:
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.
FDA Product Codes
LDJ
Enzyme Immunoassay, Cannabinoids
DJG
Enzyme Immunoassay, Opiates
DJR
Enzyme Immunoassay, Methadone
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM
Enzyme Immunoassay, Benzodiazepine
DIS
Enzyme Immunoassay, Barbiturate
DKZ
Enzyme Immunoassay, Amphetamine
LCM
Enzyme Immunoassay, Phencyclidine
LFG
Radioimmunoassay, Tricyclic Antidepressant Drugs
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 2
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 30
Storage Handling - Storage Handling Type: Storage Environment Temperature