Device
Pocguide Multi-Drug Test Panel OTC (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Manufacturer
Hangzhou Aichek Medical Technology Co., Ltd.
Hangzhou Aichek Medical Technology Co., Ltd.
Model: 1
DI: 06978151200133
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Pocguide Multi-Drug Test Panel OTC (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
70a20425-49dc-4228-875a-a513626fa885
Distribution Status:
In Commercial Distribution
DUNS Number:
548416054
Device Count:
1
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
Device ID:
06978151200133
Type:
Primary
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
NFT
Test, Amphetamine, Over The Counter
NGL
Test, Opiates, Over The Counter
PTH
Test, Barbiturate, 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
NGM
Test, Phencyclidine (Pcp), Over The Counter
NFW
Test, Cannabinoid, Over The Counter
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
4
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