FDA.reportPublic FDA data

Methamphetamine-specific 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 a specific methamphetamine 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.
GUDID devices
26
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00690286000162VERDICT®-IIMEDTOX DIAGNOSTICS, INC.6015982016-09-16
00816862026610Prime ScreenWONDFO USA CO., LTD.DWDMA-114-25BX-A2025-07-03
00850054867223Amazewell Guangzhou Decheng Biotechnology Co., LTDASUD-1145A32024-09-27
00850054867230AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-2135A32024-09-27
00850054867285AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-6125A32024-09-27
00850065976006NOBLEGuangzhou Decheng Biotechnology Co., LTDNMCup-12-01-DK2024-09-29
00850065976471AmazewellGuangzhou Decheng Biotechnology Co., LTDAFD-2642024-09-27
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114097Alltest MET500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114257Alltest MET500 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114370Alltest MET500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114523Alltest MET500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114677Alltest MET500 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114684Alltest MET500 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06970429841901co-innovationCo-Innovation Biotech Co., Ltd12P Drug Test2022-01-15
10816862026617Prime ScreenWONDFO USA CO., LTD.DWDMA-114-25BX-A2025-07-03
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-1862024-09-30
30850054867224Amazewell Guangzhou Decheng Biotechnology Co., LTDASUD-1145A32024-09-27
30850054867231AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-2135A32024-09-27
30850054867286AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-6125A32024-09-27
30850065976007NOBLEGuangzhou Decheng Biotechnology Co., LTDNMCup-12-01-DK2024-09-29
30850065976472AmazewellGuangzhou Decheng Biotechnology Co., LTDAFD-2642024-09-27
10743816000051AccuSign® MET cardPRINCETON BIOMEDITECH CORPORATIONDOA-202-35-022016-09-23
10743816000068AccuSign® MET cardPRINCETON BIOMEDITECH CORPORATIONDOA-202-10-022016-09-23
10743816000075AccuSign® MET 500 cardPRINCETON BIOMEDITECH CORPORATIONDOA-202E-35-002016-09-23
10763924315915Accutest CLEAR Methamphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KJANT PHARMACAL CORPORATIONDS3152016-09-20