ECO

GUDID 00841824104228

DOA 6 in 1 Test ECO Cup, 25Pcs/Box, CLIA Waived AMP/BUP/BZO/COC/OPI/OXY

W.H.P.M. INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00841824104228
NIH Device Record Keyfd0692e3-638a-4cfe-b512-d208b7f4650b
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO
Version Model NumberWECCUP6864
Company DUNS602085672
Company NameW.H.P.M. INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
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
GS100841824104228 [Primary]
GS100841824104235 [Unit of Use]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-04
Device Publish Date2019-02-01

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

00841824105553 - ECOII2024-08-30 DOA 14 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/PPX/TCA/THC
00841824104730 - EZ CLICK2024-08-02 DOA 12 in 1 Test EZ CLICK Cup W/ AD, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC/PH-SG-OX
00841824105409 - N/A2024-06-24 DOA 7 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, BUP/BZO/COC/mAMP/MTD/OPI/OXY
00841824105492 - ECOII2024-05-06 DOA 10 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC/SG-PH-CR
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.