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, Amphetamine (DKZ) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (7) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Enzyme Immunoassay, Opiates (DJG) (6) Reagents, Test, Tetrahydrocannabinol (DKE) (6) Thin Layer Chromatography, Methamphetamine (DJC) (5) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Phencyclidine (LCM) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Gas Chromatography, Methamphetamine (LAF) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (1)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763020363 Catalog Number : FSCDIP36104

Device Description : DOA 10 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/B DOA 10 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020370 Catalog Number : FSCCUP-19124

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/MOR/MTD/OPI/OXY/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020387 Catalog Number : FSCCUP-9124 W/AD

Device Description : DOA 12 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/B DOA 12 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/THC/PH-SG-OX

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020394 Catalog Number : FSCDIP19124

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020400 Catalog Number : FSCDIP13124

Device Description : DOA 12 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BAR DOA 12 in 1 Test Dipcard, 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 : DKZ, DIS, DJG, JXM, DIO, DJC, LAF, DJR, LCM, LDJ

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020417 Catalog Number : FSCDIP124

Device Description : DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedCOC/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DIO, DKE

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020424 Catalog Number : FSCDIP1024

Device Description : DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DIO, DKZ

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020431 Catalog Number : FSCDIP11024

Device Description : DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKZ, DKE

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020448 Catalog Number : FSCDIP1224

Device Description : DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/mAMP

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : JXM, DJC

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020455 Catalog Number : FSCDIP1324

Device Description : DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/OPI

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : JXM, DJG

Prescription Use : Yes

Device Count : 25

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