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, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Amphetamine (DKZ) (3) Thin Layer Chromatography, Methamphetamine (DJC) (3) Enzyme Immunoassay, Opiates (DJG) (2) Reagents, Test, Tetrahydrocannabinol (DKE) (2)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00857338006453 Catalog Number : FSCW1634

Device Description : DOA 3 in 1 Test Dip card, 25Pcs/Box; First Sign for HemosureBZO/mAMP/OPI

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : JXM, DJC, DIO

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006460 Catalog Number : FSCW124

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKE, DIO

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006477 Catalog Number : FSCW1024

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

Device Class : 2

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKZ, DIO

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006484 Catalog Number : FSCW11024

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKE, DKZ

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006491 Catalog Number : FSCW1224

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

Device Class : 2

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJC, JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006507 Catalog Number : FSCW1324

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJG, JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006514 Catalog Number : FSCW1424

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

Device Class : 2

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJC, DJG

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006521 Catalog Number : FSCWAM-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for HemosureAMP

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006538 Catalog Number : FSCWBZ-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for HemosureBZO

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006545 Catalog Number : FSCWCO-25

Device Description : DOA Single Test Dip card, 25Pcs/Box; First Sign for HemosureCOC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 25

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