Home GUDID 00841824105645 N/A
Primary DI 00841824105645
Brand N/A
Company W.H.P.M. INC.
Model WMA500-25
Catalog number WMA500-25
Device description DOA Single Test Dip Card, 25Pcs/Box, CLIA Waived, mAMP500
Published 2025-06-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name LAF Gas Chromatography, Methamphetamine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LAF Gas Chromatography, Methamphetamine Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841824105652 Primary GS1 0 00841824105645 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841824105652 00841824105652 841824105652 0841824105652 00841824105645 00841824105645 841824105645 0841824105645
GMDN Terms# Term, Definition table Term Definition Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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.
Regulatory Flags# DUNS number 602085672 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810173656726 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656733 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656740 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656757 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656764 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656771 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656788 Healgen Healgen Scientific Limited Liability Company LAF 2026-06-03 00810173656702 Accurate Healgen Scientific Limited Liability Company LAF 2026-06-02 10841824104737 EZ CLICK W.H.P.M. INC. LAF 2024-07-25 16936983149751 Discover milti-drug12 drugs rapid test cup Hangzhou AllTest Biotech Co., Ltd. LAF 2024-02-09 16936983144664 Discover Hangzhou AllTest Biotech Co., Ltd. LAF 2023-11-30 16936983144671 Discover Hangzhou AllTest Biotech Co., Ltd. LAF 2023-11-30 B298305250 DrugCheck Express Diagnostic Int'l, Inc. LAF 2023-11-30 10833143000067 iCup™ Instant Technologies, Inc. LAF 2023-09-12 10817763022609 First Sign W.H.P.M. INC. LAF 2022-11-17 20869419000209 Express ResultsTM Quest Diagnostics LAF 2022-03-28 10841824104843 NA W.H.P.M. INC. LAF 2021-10-12 10841824104812 ECO II Cup ® W.H.P.M. INC. LAF 2021-09-10 10817815020683 CRL Stat Dip Card W.H.P.M. INC. LAF 2021-08-25 10841824104805 NA W.H.P.M. INC. LAF 2021-08-25 10841824104782 ECO II Cup ® W.H.P.M. INC. LAF 2021-07-08 B2983057210 DrugCheck Express Diagnostic Int'l, Inc. LAF 2021-06-18 10817405021304 iScreen™ Instant Technologies, Inc. LAF 2020-08-21 10817405021311 iScreen™ Instant Technologies, Inc. LAF 2020-08-21 10817405021328 iScreen™ Instant Technologies, Inc. LAF 2020-08-21 10612479255293 McKesson MCKESSON MEDICAL-SURGICAL INC. LAF 2020-06-18 10612479255323 McKesson MCKESSON MEDICAL-SURGICAL INC. LAF 2020-06-18 10858886006480 NOBLE NOBLE MEDICAL INC LAF 2020-04-21 B2983044510 DrugCheck Express Diagnostic Int'l, Inc. LAF 2019-04-23 B2983050110 DrugCheck Express Diagnostic Int'l, Inc. LAF 2019-04-23