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) (10) Enzyme Immunoassay, Benzodiazepine (JXM) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Methadone (DJR) (10) Enzyme Immunoassay, Opiates (DJG) (10) Gas Chromatography, Methamphetamine (LAF) (9) Thin Layer Chromatography, Methamphetamine (DJC) (7) Enzyme Immunoassay, Phencyclidine (LCM) (7) Enzyme Immunoassay, Barbiturate (DIS) (7) Enzyme Immunoassay, Cannabinoids (LDJ) (7) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (5) Reagents, Test, Tetrahydrocannabinol (DKE) (3)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763020189 Catalog Number : FSCCUP-06144 W/AD

Device Description : DOA 14 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/B DOA 14 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC/PH-SG-OX

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020196 Catalog Number : FSCCUP-47104

Device Description : DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020202 Catalog Number : FSCW13124

Device Description : DOA 12 in 1 Test Dipcard, 25Pcs/Box; First Sign for HemosureAMP/BARB/BUP/BZO/COC DOA 12 in 1 Test Dipcard, 25Pcs/Box; First Sign for HemosureAMP/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® - 00817763020240 Catalog Number : FSCCUP-9124

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/MTD/OPI/OXY/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020264 Catalog Number : FSCDIP06144

Device Description : DOA 14 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BAR DOA 14 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020271 Catalog Number : FSCCUP-06144

Device Description : DOA 14 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BU DOA 14 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020288 Catalog Number : FSCCUP-04144 W/AD2

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020295 Catalog Number : FSCCUP-06144 W/AD2

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020349 Catalog Number : FSCCUP-36104

Device Description : DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BUP/BZ DOA 10 in 1 Test Cup, 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 : DJR, DKZ, DJC, DJG, DIO, DKE, JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020356 Catalog Number : FSCCUP-47104 W/AD

Device Description : DOA 10 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/ DOA 10 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC/PH-SG-OX

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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