WPX-25

GUDID 00841824104853

DOA Single Test Dip Card, 25Pcs/Box, CLIA Waived, PPX

W.H.P.M. INC.

Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
Primary Device ID00841824104853
NIH Device Record Key6866c0c6-48f6-4518-909a-e9b26a6cbf74
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberWPX-25
Catalog NumberWPX-25
Company DUNS602085672
Company NameW.H.P.M. INC.
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100841824104853 [Unit of Use]
GS110841824104850 [Primary]

FDA Product Code

JXNEnzyme Immunoassay, Propoxyphene

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-20
Device Publish Date2021-10-12

Devices Manufactured by W.H.P.M. INC.

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00841824105454 - N/A2024-04-16 DOA 9 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/MTD/OPI/OXY/THC
00841824105348 - ECOII2023-06-23 DOA 10 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BUP/BZO/COC/EDDP/mAMP/MTD/OPI/OXY/THC
00841824105249 - ECOII2023-05-26 DOA 11 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP
00841824105300 - ECOII2023-05-26 DOA 4 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived, AMP/COC/OPI/PCP/CR-NI-OX-PH-SG
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00841824101708 - ECO II Cup2023-03-01 DOA 12 in 1 Test ECO II Cup W/ AD, 25Pcs/Box ,CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP500/MDMA/MTD/MOR/OXY/PCP/TCA/PH-CR-OX
00817763022787 - First Sign®2023-02-22 DOA 9 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY

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