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) (5) Gas Chromatography, Methamphetamine (LAF) (5) Enzyme Immunoassay, Amphetamine (DKZ) (5) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Enzyme Immunoassay, Cannabinoids (LDJ) (5) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (5) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Barbiturate (DIS) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (3) Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (DIC) (1)

Premarket Exempt

No Yes

Clear

T-Cup - 00816862020304 Catalog Number : TDOA-7104A3

Device Description : 10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC with 3 AD*

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020311 Catalog Number : TDOA-7125

Device Description : 12-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020328 Catalog Number : TDOA-7125A3

Device Description : 12-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with 3 AD*

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

T-Cup - 00816862020335 Catalog Number : TDOA-8104

Device Description : 10-Panel T-Cup; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Wondfo Pregnancy Test - 00816862020342 Catalog Number : W1-C

Device Description : 1-Panel Cassette; hCG Pregnancy Test

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LCX

Prescription Use : Yes

Device Count : 25

Wondfo Pregnancy Test - 00816862020359 Catalog Number : W1-M

Device Description : 1-Midstream; hCG Pregnancy Midstream Test

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LCX

Prescription Use : Yes

Device Count : 25

Wondfo Pregnancy Test - 00816862020366 Catalog Number : W1-MII

Device Description : 1-Midstream; hCG Pregnancy Mini-Midstream Test

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : LCX

Prescription Use : Yes

Device Count : 25

Wondfo Drug Test Dip Card - 00816862020373 Catalog Number : WD-11MT

Device Description : 11-Panel Dip Drug Screen (THC/COC/MOP/AMP/MET/PCP/BAR/BZO/MDMA/MTD/OXY)

Device Class :

Duns Number: 849098897

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

Wondfo Saliva Alcohol Test - 00816862020380 Catalog Number : W53-S

Device Description : 1-Strip; Alcohol Saliva Test

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DIC

Prescription Use : Yes

Device Count : 100

Wondfo Drug Test Dip Card - 00816862020397 Catalog Number : WDAM-114

Device Description : 1-Panel Card; AMP Amphetamines

Device Class :

Duns Number: 849098897

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 25

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