Device
Identify Diagnostics ,10 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED
Manufacturer
MEDICAL DISTRIBUTION GROUP INC
MEDICAL DISTRIBUTION GROUP INC
Model: ID-AT10-1-AZ75
Catalog: ID-AT10-1-AZ75
DI: 10850013035660
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 Diagnostics ,10 Panel Multi-Drug Rapid Urine Test Cup, CLIA WAIVED
(AMP1000, BUP10, BZO300, COC300, EDDP300, FYL1, MET1000, MOP300, MTD300, OXY100, )
Contents: Test Cups - 75, Package Insert - 3, Security seal -75
For In Vitro Diagnostic Use Only.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9944dc1d-8b6e-4a75-bba4-52ffbaa396c3
Distribution Status:
In Commercial Distribution
DUNS Number:
064177324
Device Count:
75
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
Item #1 - Device ID:
00850013035663
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10850013035660
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
DJR
Enzyme Immunoassay, Methadone
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM
Enzyme Immunoassay, Benzodiazepine
DIS
Enzyme Immunoassay, Barbiturate
DKZ
Enzyme Immunoassay, Amphetamine
DJG
Enzyme Immunoassay, Opiates
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