W1124

GUDID 00841824104808

DOA 12 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/PPX/THC

W.H.P.M. INC.

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Primary Device ID00841824104808
NIH Device Record Key182416d5-78d2-49f5-a7d2-35bbfe650e3f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberW1124
Catalog NumberW1124
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
GS100841824104808 [Unit of Use]
GS110841824104805 [Primary]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-02
Device Publish Date2021-08-25

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

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
00817763022770 - Hemosure® Accu-Reader® 2023-05-18 Hemosure® Accu-Reader® A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detect
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
00841824105034 - N/A2023-02-22 DOA 13 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/PCP/PPX/TCA/THC
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