Wondfo Drug Test Dip Card WDMA-114

GUDID 00816862025453

1-Panel Card; mAMP/MET Methamphetamine

WONDFO USA CO., LTD.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816862025453
NIH Device Record Key1658f351-fe61-4ff3-9f8c-43e11b55f624
Commercial Distribution StatusIn Commercial Distribution
Brand NameWondfo Drug Test Dip Card
Version Model NumberWDMA-114
Catalog NumberWDMA-114
Company DUNS849098897
Company NameWONDFO USA CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Customer Support Contacts

Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816862025453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Wondfo Drug Test Dip Card]

008168620258281-Panel Card; THC Marijuana/Cannabinoids
008168620258041-Panel Card; TCA Tricyclic Antidepressants
008168620257981-Panel Card; PCP Phencyclidine
008168620257811-Panel Card; OXY Oxycodone
008168620257741-Panel Card; OPI Opiate 2000
0081686202576710-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
008168620257506-Panel Card; BUP,BZO,COC,MOP,MTD,OXY
008168620257435-Panel Card; AMP,BZO,COC,OPI,THC
0081686202573612-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
0081686202572910-Panel Card; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
008168620257125-Panel Card; BZO,COC,mAMP,MOP,THC
008168620257055-Panel Card; BZO,COC,mAMP,OPI,THC
0081686202569912-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
0081686202568212-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
008168620256756-Panel Card; BZO,COC,mAMP,MOP,OXY,THC
008168620256686-Panel Card; BZO,COC,mAMP,OPI,OXY,THC
008168620256515-Panel Card; COC,mAMP,MDMA,OPI,THC
0081686202564410-Panel Card; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC
0081686202563710-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
008168620256205-Panel Card; COC,mAMP,OPI,OXY,THC
0081686202561312-Panel Card; AMP,BAR,BUP,BZO,COC,MDMA,MTD,TCA,OPI,OXY,PCP,THC
0081686202560610-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
008168620255909-Panel Card; AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
008168620255837-Panel Card; AMP,BZO,COC,mAMP,OPI,OXY,THC
008168620255766-Panel Card; AMP,BZO,COC,mAMP,OPI,THC
008168620255695-Panel Card; AMP,COC,mAMP,OPI,THC
008168620255523-Panel Card; COC,mAMP,THC
008168620255456-Panel Card; AMP,COC,mAMP,OPI,PCP,THC
008168620255385-Panel Card; AMP,COC,OPI,PCP,THC
008168620255214-Panel Card; COC,mAMP,OPI,THC
0081686202551412-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,THC
0081686202550712-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,THC
0081686202549110-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
008168620254841-Panel Card; MTD Methadone
008168620254771-Panel Card; MOP Morphine
008168620254601-Panel Card; MDMA Ecstasy-MDMA
008168620254531-Panel Card; mAMP/MET Methamphetamine
008168620254461-Panel Card; COC Cocaine
008168620254391-Panel Card; BZO Benzodiasepines
008168620254151-Panel Card; BUP Buprenorphine
008168620254081-Panel Card; BAR Barbiturates
008168620253921-Panel Card; AMP Amphetamines
108168620210326-Panel Card; AMP,BAR,BZO,COC,MOP,OXY
108168620208201-Panel Card; THC Marijuana/Cannabinoids
108168620208061-Panel Card; TCA Tricyclic Antidepressants
108168620207901-Panel Card; PCP Phencyclidine
108168620207831-Panel Card; OXY Oxycodone
108168620207761-Panel Card; OPI Opiate 2000
1081686202076910-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
108168620207526-Panel Card; BUP,BZO,COC,MOP,MTD,OXY
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