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, Cocaine And Cocaine Metabolites (DIO) (7) Enzyme Immunoassay, Opiates (DJG) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Enzyme Immunoassay, Methadone (DJR) (4) Reagents, Test, Tetrahydrocannabinol (DKE) (4) Enzyme Immunoassay, Barbiturate (DIS) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Gas Chromatography, Methamphetamine (LAF) (2) Thin Layer Chromatography, Methamphetamine (DJC) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2) Reagent, Occult Blood (KHE) (1)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00857338006897 Catalog Number : FSCECOII-4854

Device Description : DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/C DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC/MTD/OPI/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006910 Catalog Number : FSCECOII-5764

Device Description : DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/COC/mAMP/MTD/OPI/OXY

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

HEMOSURE® - 00857338006934 Catalog Number : T1-CK50MUS

Device Description : Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers (Made in USA)

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

FIRST SIGN® - 00857338006941 Catalog Number : FSCECOII-47104 W/AD

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006958 Catalog Number : FSCECOII-9124 W/AD

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

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® - 00857338006965 Catalog Number : FSCECOII-264 W/AD2

Device Description : DOA 6 in 1 Test ECO II Cup W/ AD, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC DOA 6 in 1 Test ECO II Cup W/ AD, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/THC/PH-SG-CR

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006989 Catalog Number : FSCECOII-1984

Device Description : DOA 8 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/BARB/BZO/COC/O DOA 8 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/BARB/BZO/COC/OPI/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006996 Catalog Number : FSCDIP1984

Device Description : DOA 8 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BAR DOA 8 in 1 Test Dipcard, 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

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