Model: HDOA-1104C
DI: 00810173656405
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
K240686
10 Panel DOA Dip Card: AMP1000, BAR300, BUP10, BZO300,
COC300, MET1000, MTD300, OPI2000, OXY100, THC50
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3dcca29c-4674-42c4-bc6a-28ac8ea9e013
Distribution Status:
In Commercial Distribution
DUNS Number:
031802328
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
Item #1 - Pkg Type:
inner pack
Item #1 - Device ID:
10810173656402
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810173656405
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810173656405
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
case
Item #3 - Device ID:
20810173656409
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
20
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10810173656402
Item #3 - 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
LFG
Radioimmunoassay, Tricyclic Antidepressant Drugs
LCM
Enzyme Immunoassay, Phencyclidine
DJR
Enzyme Immunoassay, Methadone
DIS
Enzyme Immunoassay, Barbiturate
JXM
Enzyme Immunoassay, Benzodiazepine
DJG
Enzyme Immunoassay, Opiates
LAF
Gas Chromatography, Methamphetamine
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ
Enzyme Immunoassay, Cannabinoids
DKZ
Enzyme Immunoassay, Amphetamine
JXN
Enzyme Immunoassay, Propoxyphene
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