FDA.reportPublic FDA data

NA

Primary DI
00841824102156
Brand
NA
Company
W.H.P.M. INC.
Model
WOX-25
Catalog number
WOX-25
Device description
DOA Single Test Dip Card, 25Pcs/Box, CLIA WaivedOXY
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
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824102156PrimaryGS10
00841824100114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102156008418241021568418241021560841824102156
00841824100114008418241001148418241001140841824100114

GMDN Terms#

Term, Definition table
TermDefinition
Oxycodone 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 oxycodone 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
00841824104167ECOIIECOII-4104 W/AD6ECOII-4104 W/AD62026-07-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28