Device
13-Panel T-Cup; AMP1000,BAR300,BUP10,BZO300,COC300,MDMA500,MET1000,MOP300,MTD300,OXY100,PCP25,THC50,FTY1
Manufacturer
WONDFO USA CO., LTD.
WONDFO USA CO., LTD.
Model: TDOA-6135F
DI: 00816862028362
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
13-Panel T-Cup; AMP1000,BAR300,BUP10,BZO300,COC300,MDMA500,MET1000,MOP300,MTD300,OXY100,PCP25,THC50,FTY1
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
320f12c0-f6eb-4edf-8686-8a684e78f7f5
Distribution Status:
In Commercial Distribution
DUNS Number:
849098897
Device Count:
25
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 - Device ID:
00816862028355
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00816862028362
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
PTH
Test, Barbiturate, Over The Counter
NGL
Test, Opiates, Over The Counter
NFV
Test, Benzodiazepine, Over The Counter
NFY
Test, Cocaine And Cocaine Metabolites, Over The Counter
NGG
Test, Methamphetamine, Over The Counter
PTG
Test, Methadone, Over The Counter
LCM
Enzyme Immunoassay, Phencyclidine
NFW
Test, Cannabinoid, Over The Counter
NFT
Test, Amphetamine, Over The Counter
Premarket Submissions
Submission Number:
K252550
Supplement Number:
000