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) (4) Test, Phencyclidine (Pcp), Over The Counter (NGM) (4) Test, Barbiturate, Over The Counter (PTH) (4) Test, Benzodiazepine, Over The Counter (NFV) (4) Test, Cannabinoid, Over The Counter (NFW) (4) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (4) Test, Methadone, Over The Counter (PTG) (4) Test, Methamphetamine, Over The Counter (NGG) (4) Test, Tricyclic Antidepressants, Over The Counter (QAW) (2) Test, Amphetamine, Over The Counter (NFT) (2) Test, Propoxyphene, Over The Counter (QBF) (2) Reagent, Coronavirus Serological (QKO) (1)

Premarket Exempt

No Yes

Clear

AssureTech Panel Dip Tests - 06952804802646 Catalog Number :

Device Description : 12 Strips, including MOR2000

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

AssureTech Quick Cup Test - 06952804802653 Catalog Number :

Device Description : 12 strips, including MOR2000

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Fastep COVID-19 IgG/IgM Rapid Test Device - 06952804805029 Catalog Number :

Device Class :

Duns Number: 530757741

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : No

Device Count : 1

AssureTech Panel Dip Tests - 06952804830212 Catalog Number :

Device Description : AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, P AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

AssureTech Quick Cup Tests - 06952804830229 Catalog Number :

Device Class : 2

Duns Number: 530757741

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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