FDA.reportPublic FDA data

NA

Primary DI
00841824102101
Brand
NA
Company
W.H.P.M. INC.
Model
WMA-25
Catalog number
WMA-25
Device description
DOA Single Test Dipcard, 25Pcs/Box Clia Waived mAMP
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824102101PrimaryGS10
00841824100060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102101008418241021018418241021010841824102101
00841824100060008418241000608418241000600841824100060

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapidA 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. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602085672
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841824105577ECOIIECOII-6664ECOII-66642026-03-19
00841824101845ECOIIECOII-6664ECOII-66642026-03-19
00811925030009ADS MedicalT1-CK30-ADSM2018-03-29
00811925030023ADS MedicalT1-CK30T-ADSM2018-03-29
00811925030030ADS MedicalT1-CK50-ADSM2018-03-29
00811925030047ADS MedicalT1-CT30-ADSM2018-03-29
00811925030054ADS MedicalT1-CT50-ADSM2018-03-29
00811925030061ADS MedicalT1-TB30-ADSM2018-03-29
00811925030078ADS MedicalT1-TB50-ADSM2018-03-29
00841824105706N/AW944W9442025-12-04
00841824105690EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105683EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105652N/AWMA500-25WMA500-252025-06-13
00841824105645N/AWMA500-25WMA500-252025-06-13
00841824105560ECOIIECOII-07144ECOII-071442024-08-22
00841824105553ECOIIECOII-07144ECOII-071442024-08-22
10841824104737EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824104730EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824105416N/AW4374W43742024-06-14
00841824105409N/AW4374W43742024-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B298307220DrugCheck Express Diagnostic Int'l, Inc.LAF2026-02-19
10841824104737EZ CLICKW.H.P.M. INC.LAF2024-07-25
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LAF2024-02-09
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
B298305250DrugCheck Express Diagnostic Int'l, Inc.LAF2023-11-30
10833143000067iCup™Instant Technologies, Inc.LAF2023-09-12
10817763022609First SignW.H.P.M. INC.LAF2022-11-17
20869419000209Express ResultsTM Quest DiagnosticsLAF2022-03-28
10841824104843NAW.H.P.M. INC.LAF2021-10-12
10841824104812ECO II Cup ®W.H.P.M. INC.LAF2021-09-10
10817815020683CRL Stat Dip CardW.H.P.M. INC.LAF2021-08-25
10841824104805NAW.H.P.M. INC.LAF2021-08-25
10841824104782ECO II Cup ®W.H.P.M. INC.LAF2021-07-08
B2983057210DrugCheckExpress Diagnostic Int'l, Inc.LAF2021-06-18
10817405021304iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021311iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LAF2020-08-21
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10858886006480NOBLE NOBLE MEDICAL INCLAF2020-04-21
B2983044510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050110DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050410DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050810DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983055410DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983056010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983058010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983060010DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983069510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23