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) (8) Enzyme Immunoassay, Opiates (DJG) (8) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (8) Gas Chromatography, Methamphetamine (LAF) (6) Enzyme Immunoassay, Barbiturate (DIS) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Cannabinoids (LDJ) (5) Enzyme Immunoassay, Phencyclidine (LCM) (5) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Reagents, Test, Tetrahydrocannabinol (DKE) (2) Drug Mixture Control Materials (DIF) (2)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763021315 Catalog Number : FSCDIP12104

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/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021551 Catalog Number : FSCCUP-1984

Device Description : DOA 8 in 1 Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BZO/COC DOA 8 in 1 Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BZO/COC/OPI/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021568 Catalog Number : FSCCUP-1104

Device Description : DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/B DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021575 Catalog Number : FSCDIP1104

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/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021605 Catalog Number : FSCCUP-3104

Device Description : DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZ DOA 10 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021612 Catalog Number : FSCDIP3104

Device Description : DOA 10 in 1 Test Dipcard, 25Pcs/Box ; First Sign for Hemosure; CLIA WaivedAMP/BA DOA 10 in 1 Test Dipcard, 25Pcs/Box ; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021643 Catalog Number : FSCDIP754

Device Description : DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO/COC/OPI/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021650 Catalog Number : FSCCUP-6164

Device Description : DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for HemosureAMP/BZO/COC/mAMP/MOR/OXY

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021681 Catalog Number : D0115-TC01

Device Description : DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (5mL each); First DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (5mL each); First Sign for Hemosure

Device Class : 1

Duns Number: 806777541

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

FIRST SIGN® - 00817763021698 Catalog Number : D0115-TC02

Device Description : DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); Firs DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for Hemosure

Device Class : 1

Duns Number: 806777541

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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