FDA.reportPublic FDA data

NA

Primary DI
00841824101173
Brand
NA
Company
W.H.P.M. INC.
Model
WAM-25
Catalog number
WAM-25
Device description
DOA Single Test Dipcard, 25Pcs/Box Clia Waived AMP
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
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824101173PrimaryGS10
00841824100039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824101173008418241011738418241011730841824101173
00841824100039008418241000398418241000390841824100039

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 a specific amphetamine 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
00841824101845ECOIIECOII-6664ECOII-66642026-03-19
00841824105706N/AW944W9442025-12-04
00841824105683EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105645N/AWMA500-25WMA500-252025-06-13
00841824105553ECOIIECOII-07144ECOII-071442024-08-22
00841824104730EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824105409N/AW4374W43742024-06-14
00841824105492ECOIIECOII-4104 W/AD2ECOII-4104 W/AD22024-04-26
00841824105454N/AW4494W44942024-04-08
00841824105348ECOIIECOII-83104ECOII-831042023-06-15
00841824105249ECOIIECOII-87114ECOII-871142023-05-18
00841824105300ECOIIECOII-2744 W/AD9ECOII-2744 W/AD92023-05-18
00817763022770Hemosure® Accu-Reader® A1002023-05-10
00841824101708ECO II CupECOII-73124 W/AD4ECOII-73124 W/AD42022-11-01
00817763022787First Sign®FSCCUP-3994FSCCUP-39942023-02-14
00841824105034N/AW15134W151342023-02-14
00841824105188ECO II CupECOII-22114ECOII-221142022-12-01
00817815020730CRL STATKCUR920127KCUR9201272022-11-22
00817763022602First SignFSCDIP18114FSCDIP181142022-11-17
00841824105164n/aW6074 W/AD6W6074 W/AD62022-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841824101845ECOIIW.H.P.M. INC.DKZ2026-03-19
B2986051360DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-20
B2987050460DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-20
B298307220DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
B298605010DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
10810173655665HealgenHealgen Scientific Limited Liability CompanyDKZ2026-01-30
B298606220DrugCheck Express Diagnostic Int'l, Inc.DKZ2025-12-09
00841824105706N/AW.H.P.M. INC.DKZ2025-12-04
00850013035748Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDKZ2025-12-04
00841824105683EZ CLICKW.H.P.M. INC.DKZ2025-11-20
00850721007501Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDKZ2025-09-11
00850076289003Hysen Drug Test CupsHYSEN INC.DKZ2025-08-04
00850076289010Hysen Drug Test CardsHYSEN INC.DKZ2025-08-04
208170380222709 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2025-06-06
208170380222875 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2025-06-06
20817038022263u-CupTM Drug Test ScreenUCP BIOSCIENCES, INC.DKZ2025-04-09
00858886006841Noble Drug Test Cup (Urine)NOBLE MEDICAL INCDKZ2025-01-17
10815845024381SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DKZ2024-12-17
10810124273160SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273177SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273658SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273665SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
00841824105553ECOIIW.H.P.M. INC.DKZ2024-08-22
00841824104730EZ CLICKW.H.P.M. INC.DKZ2024-07-25
10840050517496Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
10840050517526Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
10816862024286T-DipWONDFO USA CO., LTD.DKZ2024-05-17
20817038022249inSight 12 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2024-05-16
00841824105492ECOIIW.H.P.M. INC.DKZ2024-04-26
20817038022225OEM 81-13 Drug Test 5 Panel Test CupUCP BIOSCIENCES, INC.DKZ2024-04-09