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

Reagents, Test, Tetrahydrocannabinol (DKE) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Amphetamine (DKZ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Phencyclidine (LCM) (3) Enzyme Immunoassay, Barbiturate (DIS) (2)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00857338006651 Catalog Number : FSCECOII-874

Device Description : DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/ DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006668 Catalog Number : FSCECOII-174

Device Description : DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/ DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/OXY/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® - 00857338006767 Catalog Number : FSCW19124

Device Description : DOA 12 in 1 Test Dip card, 25Pcs/Box; First Sign for HemosureAMP/BARB/BUP/BZO/CO DOA 12 in 1 Test Dip card, 25Pcs/Box; First Sign for HemosureAMP/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® - 00857338006774 Catalog Number : FSCW36104

Device Description : DOA 10 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mA DOA 10 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure 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® - 00857338006781 Catalog Number : FSCW2974

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

Device Class : 2

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006798 Catalog Number : FSCECOII-2974

Device Description : DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/m DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/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® - 00857338006811 Catalog Number : FSCECOII-36104

Device Description : DOA 10 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/ DOA 10 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure 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® - 00857338006835 Catalog Number : FSCECOII-19124

Device Description : DOA 12 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/BARB/BUP/BZO/ DOA 12 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/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® - 00857338006859 Catalog Number : FSCECOII-264

Device Description : DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/BZO/COC/mAMP/OPI/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® - 00857338006880 Catalog Number : FSCW4854

Device Description : DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for HemosureAMP/COC/MTD/OPI/THC

Device Class : 2

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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