Device
Identify Health, 9 Panel Drug Screen Test Cup, CLIA Waived
Manufacturer
MEDICAL DISTRIBUTION GROUP INC
MEDICAL DISTRIBUTION GROUP INC
Model: ID-H9-1-AZ1
Catalog: ID-H9-1
DI: 10850013035943
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Distribution End: 2046-05-12
Description
Identify Health, 9 Panel Drug Screen Test Cup, CLIA Waived
(AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR300, OXY100)
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:
289950bb-81f4-4e48-a585-23279c9d158b
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:
10850013035943
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
DJC
Thin Layer Chromatography, Methamphetamine
DJR
Enzyme Immunoassay, Methadone
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM
Enzyme Immunoassay, Benzodiazepine
DJG
Enzyme Immunoassay, Opiates
DKZ
Enzyme Immunoassay, Amphetamine
DIS
Enzyme Immunoassay, Barbiturate