Model: M321002-EI
DI: G474M321002EI0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
10 Panel Oral Fluid Drug Test
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ed6184dc-7c2c-41ac-a735-363f8c53737e
Distribution Status:
In Commercial Distribution
DUNS Number:
117581283
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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
Item #1 - Device ID:
G474M321002EI0
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Pkg Type:
Box
Item #2 - Device ID:
G474M321002EI1
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
25
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
G474M321002EI0
Item #2 - Device ID Issuing Agency:
HIBCC
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
PUX
Test, Amphetamine, Employment And Insurance Testing, Exempt
PVA
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVJ
Test, Cannabinoid, Employment And Insurance Testing, Exempt
PVD
Test, Methamphetamine, Employment And Insurance Testing, Exempt
PVH
Test, Opiates, Employment And Insurance Testing, Exempt
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