FDA.reportPublic FDA data

NA

Primary DI
00841824102590
Brand
NA
Company
W.H.P.M. INC.
Model
W254 W/AD
Catalog number
W254W/AD
Device description
DOA 5 in 1 Test Dipcard W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
Published
2016-05-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00841824102590PrimaryGS10
00841824100411Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102590008418241025908418241025900841824102590
00841824100411008418241004118418241004110841824100411

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse 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
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#

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