Device
Identify Health, 6 Panel Drug Screen Test Cup, CLIA Waived
Manufacturer
MEDICAL DISTRIBUTION GROUP INC
Model: ID-H6-1-AZ1 Catalog: ID-H6-1-AZ1 DI: 10850013035592 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-21 Current Version: 2026-05-29 Distribution End: 2046-05-21
Description
Identify Health, 6 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BZO300, COC150, OPI300, OXY100, THC50) Contents: Test Cups - 1, Package Insert -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: 120fea12-d0d1-4c1c-8faf-370474f02798
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: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 10850013035592
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
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM
Enzyme Immunoassay, Benzodiazepine
DJG
Enzyme Immunoassay, Opiates
DKZ
Enzyme Immunoassay, Amphetamine
LDJ
Enzyme Immunoassay, Cannabinoids