HEMOSURE INC.

Address:5358 Irwindale Avenue,Irwindale,CA,91706,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, Opiates (DJG) (5) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Amphetamine (DKZ) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Thin Layer Chromatography, Methamphetamine (DJC) (3) Enzyme Immunoassay, Methadone (DJR) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Reagents, Test, Tetrahydrocannabinol (DKE) (2) Enzyme Immunoassay, Phencyclidine (LCM) (1) Gas Chromatography, Methamphetamine (LAF) (1) Enzyme Immunoassay, Barbiturate (DIS) (1)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763020769 Catalog Number : FSCDIP2974

Device Description : DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/mAMP/MOR/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKZ, DJC, DJG, DIO, DKE, JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020776 Catalog Number : FSCDIPAM-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020783 Catalog Number : FSCDIPBU-25

Device Description : DOA Single Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBUP

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020790 Catalog Number : FSCDIPBZ-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020806 Catalog Number : FSCDIPCO-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedCOC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020813 Catalog Number : FSCDIPMA-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedmAMP

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020820 Catalog Number : FSCDIPOP-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedOPI

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020837 Catalog Number : FSCDIPTH-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedTHC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKE

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020844 Catalog Number : FSCCUP-13124

Device Description : DOA 12 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BU DOA 12 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020967 Catalog Number : FSCCUP-2184

Device Description : DOA 8 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/ DOA 8 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/MOR/MTD/OXY/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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