Device
D12.49-1VAF Internal Code: D12.49-1VAF-TU - OXY100 BZO300 MOR300 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 FYL1+ OXI/CRE/PH
Manufacturer
BTNX Inc
BTNX Inc
Model: D12.49-1VAF
DI: 10722066015053
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
D12.49-1VAF Internal Code: D12.49-1VAF-TU - OXY100 BZO300 MOR300 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 FYL1+ OXI/CRE/PH
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
573ce5c0-098a-4cbc-b6f7-eee364f757f4
Distribution Status:
In Commercial Distribution
DUNS Number:
251005005
Device Count:
25
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
Case
Item #1 - Device ID:
20722066015050
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
100
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10722066015053
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10722066015053
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00722066015056
Item #3 - Device ID Type:
Unit of Use
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
NFY
Test, Cocaine And Cocaine Metabolites, Over The Counter
NFV
Test, Benzodiazepine, Over The Counter
NFW
Test, Cannabinoid, Over The Counter
NGG
Test, Methamphetamine, Over The Counter
NGL
Test, Opiates, Over The Counter
NGM
Test, Phencyclidine (Pcp), Over The Counter
PTG
Test, Methadone, Over The Counter
PTH
Test, Barbiturate, Over The Counter
QAW
Test, Tricyclic Antidepressants, Over The Counter
QBF
Test, Propoxyphene, Over The Counter