WONDFO USA CO., LTD.

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

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Filters

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, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Amphetamine (DKZ) (9) Gas Chromatography, Methamphetamine (LAF) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (7) Enzyme Immunoassay, Phencyclidine (LCM) (6) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4) Enzyme Immunoassay, Propoxyphene (JXN) (3)

Premarket Exempt

No Yes

Clear

Wondfo Key Cup - 00816862020007 Catalog Number : KDOA-254

Device Description : 5-Panel Key Cup; AMP,COC,mAMP,OPI,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DIO, DKZ

Prescription Use : Yes

Device Count : 25

Wondfo Key Cup - 00816862020014 Catalog Number : KDOA-264

Device Description : 6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DIO, JXM, DKZ

Prescription Use : Yes

Device Count : 25

Wondfo Key Cup - 00816862020021 Catalog Number : KDOA-274

Device Description : 7-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DIO, JXM, DKZ

Prescription Use : Yes

Device Count : 25

Wondfo Key Cup - 00816862020038 Catalog Number : KDOA-3104

Device Description : 10-Panel Key Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Wondfo Key Cup - 00816862020045 Catalog Number : KDOA-7104

Device Description : 10-Panel Key Cup; BAR,BZO,BUP,COC,mAMP,MTD,OPI,OXY,TCA,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020052 Catalog Number : TDOA-1144

Device Description : 14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020069 Catalog Number : TDOA-1144A3

Device Description : 14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC with 3 AD*

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020076 Catalog Number : TDOA-1145A3

Device Description : 14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,TCA,THC with 3 AD*

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020083 Catalog Number : TDOA-154

Device Description : 5-Panel T-Cup; AMP,COC,OPI,PCP,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LDJ, LCM, DJG, DIO, DKZ

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020090 Catalog Number : TDOA-164

Device Description : 6-Panel T-Cup; AMP,COC,MET,OPI,PCP,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LDJ, LCM, DJG, LAF, DIO, DKZ

Prescription Use : Yes

Device Count : 25

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