ASSURE TECH. (HANGZHOU) CO., LTD.

Address:Building 4, No. 1418-50, Moganshan Road, Gongshu District,Hangzhou Zhejiang,CN

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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

Test, Opiates, Over The Counter (NGL) (6) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (6) Test, Methamphetamine, Over The Counter (NGG) (6) Test, Phencyclidine (Pcp), Over The Counter (NGM) (5) Test, Amphetamine, Over The Counter (NFT) (5) Test, Barbiturate, Over The Counter (PTH) (5) Test, Benzodiazepine, Over The Counter (NFV) (5) Test, Cannabinoid, Over The Counter (NFW) (5) Test, Methadone, Over The Counter (PTG) (5) Test, Tricyclic Antidepressants, Over The Counter (QAW) (4) Test, Propoxyphene, Over The Counter (QBF) (4) Visual, Pregnancy Hcg, Prescription Use (JHI) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1)

Premarket Exempt

No Yes

Clear

Ecstasy Panel Dip - 06952804801823 Catalog Number :

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : NGG

Prescription Use : No

Device Count : 1

hCG Pregnancy Serum/Urine Combo Test Strip(10/20) - 06952804801830 Catalog Number :

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

HCG Pregnancy Serum/Urine Combo Test Cassette (20/20) - 06952804801847 Catalog Number :

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

DOA Urine Cup 004 - 06952804801885 Catalog Number : MD-U65

Device Description : COC300/AMP1000/MET1000/THC50/MOR 2000

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DOA Urine Cup 004 - 06952804801892 Catalog Number : MD-U610

Device Description : AMP1000/BAR300/BZO300/COC300/MET1000/MOR2000/MTD300/OXY100/PCP25/THC50

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : NFT, LDJ, NGM, PTG, NGL, NGG, NFY, NFV, PTH

Prescription Use : No

Device Count : 1

OPI/COC/THC Tests Panel - 06952804801946 Catalog Number :

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : NFY, NGL, NFW

Prescription Use : No

Device Count : 1

AssureTech Panel Dip Tests - 06952804802608 Catalog Number :

Device Description : 15 Strips, including MOR300

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : NFT, QBF, QAW, PTH, PTG, NGM, NGL, NGG, NFY, NFW, NFV

Prescription Use : No

Device Count : 1

AssureTech Quick Cup Tests - 06952804802615 Catalog Number :

Device Description : 15 strips, including MOR300

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : QBF, QAW, PTH, PTG, NGM, NGL, NGG, NFY, NFW, NFV, NFT

Prescription Use : No

Device Count : 1

AssureTech Panel Dip Tests - 06952804802622 Catalog Number :

Device Description : 15 strips, including MOR2000

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : QBF, QAW, PTH, PTG, NGM, NGL, NGG, NFY, NFW, NFV, NFT

Prescription Use : No

Device Count : 1

AssureTech Quick Cup Tests - 06952804802639 Catalog Number :

Device Description : 15 strips, including MOR2000

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

Product Code : QBF, QAW, PTH, PTG, NGM, NGL, NGG, NFY, NFW, NFV, NFT

Prescription Use : No

Device Count : 1

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