WONDFO USA CO., LTD.

Address:545 WILLOWBROOK CENTER PKWY STE B,WILLOW BROOK,IL,60527,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Opiates (DJG) (4) Gas Chromatography, Methamphetamine (LAF) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Enzyme Immunoassay, Methadone (DJR) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1)

Premarket Exempt

Yes No

Clear

Wondfo Drug Test Dip Card - 00816862020403 Catalog Number : WDBA-114

Device Description : 1-Panel Card; BAR Barbiturates

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020410 Catalog Number : WDBU-114

Device Description : 1-Panel Card; BUP Buprenorphine

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Cassette - 00816862020427 Catalog Number : WDBU-201

Device Description : 1-Panel Cassette; BUP Buprenorphine

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020434 Catalog Number : WDBZ-114

Device Description : 1-Panel Card; BZO Benzodiasepines

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020441 Catalog Number : WDCO-114

Device Description : 1-Panel Card; COC Cocaine

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020458 Catalog Number : WDMA-114

Device Description : 1-Panel Card; mAMP/MET Methamphetamine

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020465 Catalog Number : WDMD-114

Device Description : 1-Panel Card; MDMA Ecstasy-MDMA

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020472 Catalog Number : WDMO-114

Device Description : 1-Panel Card; MOP Morphine

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020489 Catalog Number : WDMT-114

Device Description : 1-Panel Card; MTD Methadone

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020496 Catalog Number : WDOA-1104

Device Description : 10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LDJ, LFG, LCM, DJG, DJR, LAF, DIO, JXM, DIS, DKZ

Prescription Use : Yes

Device Count : 25

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