Device
Pocguide Multi-Drug Test Cup OTC (CLIA Waived), 12-Panel, 25T/Box;
Manufacturer
Hangzhou Aichek Medical Technology Co., Ltd.
Hangzhou Aichek Medical Technology Co., Ltd.
Model: 1
DI: 06978151200119
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 Cup 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:
ba3d71ee-41f9-458a-9330-15872a3d7758
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:
06978151200119
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
Premarket Submissions
Submission Number:
K242077
Supplement Number:
000
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