Hangzhou AllTest Biotech Co., Ltd.

Address:No. 550, Yinhai Street,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 System, Nicotine, Cotinine, Metabolites (MRS) (3) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Reagent, Occult Blood (KHE) (1)

Premarket Exempt

No Yes

Clear

Pregnancy (hCG) Rapid Test Midstream - 06970277512404 Catalog Number : FHC-103H

Device Description : Pregnancy (hCG) Rapid Test Midstream

Device Class : 2

Duns Number: 543254717

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

FOB Rapid Test Cassette - 06970277512473 Catalog Number : TFO-602

Device Description : FOB Rapid Test Cassette Box of 25 kits.

Device Class :

Duns Number: 543254717

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 25

Cotinine (COT) Rapid Test Cassette - 06970277512503 Catalog Number : DCT-102

Device Description : Cotinine (COT) Rapid Test Cassette Box of 40

Device Class :

Duns Number: 543254717

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : No

Device Count : 40

Cotinine (COT) Rapid Test Panel - 06970277512527 Catalog Number : DCT-114

Device Description : Cotinine (COT) Rapid Test Panel box of 40

Device Class :

Duns Number: 543254717

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : No

Device Count : 40

Cotinine (COT) Rapid Test Dipstick - 06970277512541 Catalog Number : DCT-101

Device Description : Cotinine (COT) Rapid Test Dipstick Box of 50

Device Class :

Duns Number: 543254717

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : No

Device Count : 50

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