FDA.reportPublic FDA data

Amphetamine-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 amphetamine 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
76
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850011007136Tanner Scientific®MERCEDES MEDICAL, LLCTNR DOA13A2016-08-15
00850011007570Platinum+MERCEDES MEDICAL, LLCMER MMDOAY61252018-08-10
00850054867049AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-10106EUO2024-09-26
00850054867056AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-1116PA2024-09-26
00850054867063AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-3124-OTC2024-09-26
00850054867070AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-196A2024-09-26
00850054867087AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-256EUO2024-09-26
00850054867094AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-166EUO2024-09-26
00850054867100AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-2762024-09-27
00850054867117AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-744EUO2024-09-27
00850054867131AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-154EUO2024-09-27
00850054867148AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-10106EUO2024-09-26
00850054867162AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-154EUO2024-09-26
00850054867179AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-744EUO2024-09-26
00850054867186AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-166EUO2024-09-26
00850054867193AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-256EUO2024-09-26
00850054867315AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-81052024-09-27
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-396FPA 2024-09-29
00850054867940UScreenGuangzhou Decheng Biotechnology Co., LTDUSSCUPA-14CLIA2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-12106EUO2024-09-29
00850065976082NOBLEGuangzhou Decheng Biotechnology Co., LTDNMCardA-09-37-DK2024-09-29
00850065976112UScreenGuangzhou Decheng Biotechnology Co., LTDUSSCUPA-10M2024-09-29
00850065976242UScreenGuangzhou Decheng Biotechnology Co., LTDUSSDIP-10P2024-09-29
00850065976259UScreenGuangzhou Decheng Biotechnology Co., LTDUSSDIP-10BUP2024-09-29
00850065976280UScreen OralGuangzhou Decheng Biotechnology Co., LTDUSSORAL-5NT-EUO2024-09-27
00850065976297UScreen OralGuangzhou Decheng Biotechnology Co., LTDUSSORAL-10BUP-EUO2024-09-27
00850065976464AmazewellGuangzhou Decheng Biotechnology Co., LTDAFD-2542024-09-27
00850065976518AmazewellGuangzhou Decheng Biotechnology Co., LTDAFD-41042024-09-27
06936983113878Alltest AMP500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-17
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114196Alltest AMP500 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114455Alltest AMP500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114592Alltest AMP500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114608Alltest AMP500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-21
06936983114745Alltest AMP500 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-22
06970429841345DTPMCo-Innovation Biotech Co., Ltd13P2023-12-08
06970429841444co-innovationCo-Innovation Biotech Co., Ltd14P Drug Test2022-01-15
06974464591357One Step® 7-PANEL MULTI DRUG URINE TESTGuangzhou Decheng Biotechnology Co., LTD5T2026-03-31
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-156EUO2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-2662024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-2762024-09-30
00383173000221MGC HEALTHGuangzhou Decheng Biotechnology Co., LTD1T2024-09-27
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-496NTEUO2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-266EUO2024-09-29
00850054867803AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-276EUO2024-09-29
00850065976235UScreenGuangzhou Decheng Biotechnology Co., LTDUSSDIP-10M2024-09-29
30850054867101AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-2762024-09-27
30850054867118AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-744EUO2024-09-27
30850054867132AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-154EUO2024-09-27
30850054867316AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-81052024-09-27
30850054867897AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-396FPA 2024-09-29
30850054867941UScreenGuangzhou Decheng Biotechnology Co., LTDUSSCUPA-14CLIA2024-09-29
30850054867965AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-12106EUO2024-09-29
30850065976083NOBLEGuangzhou Decheng Biotechnology Co., LTDNMCardA-09-37-DK2024-09-29
30850065976113UScreenGuangzhou Decheng Biotechnology Co., LTDUSSCUPA-10M2024-09-29
30850065976243UScreenGuangzhou Decheng Biotechnology Co., LTDUSSDIP-10P2024-09-29
30850065976250UScreenGuangzhou Decheng Biotechnology Co., LTDUSSDIP-10BUP2024-09-29
30850065976281UScreen OralGuangzhou Decheng Biotechnology Co., LTDUSSORAL-5NT-EUO2024-09-27
30850065976298UScreen OralGuangzhou Decheng Biotechnology Co., LTDUSSORAL-10BUP-EUO2024-09-27
30850065976465AmazewellGuangzhou Decheng Biotechnology Co., LTDAFD-2542024-09-27
30850065976519AmazewellGuangzhou Decheng Biotechnology Co., LTDAFD-41042024-09-27
30850054867040AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-10106EUO2024-09-26
30850054867057AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-1116PA2024-09-26
30850054867064AmazewellGuangzhou Decheng Biotechnology Co., LTDASUD-3124-OTC2024-09-26
30850054867071AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-196A2024-09-26
30850054867088AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-256EUO2024-09-26
30850054867095AmazewellGuangzhou Decheng Biotechnology Co., LTDDPO-166EUO2024-09-26
30850054867149AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-10106EUO2024-09-26
30850054867163AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-154EUO2024-09-26
30850054867170AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-744EUO2024-09-26
30850054867187AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-166EUO2024-09-26
30850054867194AmazewellGuangzhou Decheng Biotechnology Co., LTDLTO-256EUO2024-09-26
16970429841342DTPMCo-Innovation Biotech Co., Ltd13P2023-12-08
10743816000105AccuSign® AMP cardPRINCETON BIOMEDITECH CORPORATIONDOA-204-35-022016-09-23
10743816000112AccuSign® AMP cardPRINCETON BIOMEDITECH CORPORATIONDOA-204-10-022016-09-23
10763924311917Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitJANT PHARMACAL CORPORATIONDS3112016-09-20