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, Opiates (DJG) (8) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Reagents, Test, Tetrahydrocannabinol (DKE) (7) Thin Layer Chromatography, Methamphetamine (DJC) (7) Enzyme Immunoassay, Amphetamine (DKZ) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00857338006552 Catalog Number : FSCWMA-25

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006569 Catalog Number : FSCWOP-25

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006576 Catalog Number : FSCWTH-25

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKE

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006583 Catalog Number : FSCECOII-154

Device Description : DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/COC/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006590 Catalog Number : FSCECOII-254

Device Description : DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/COC/mAMP/OPI/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006606 Catalog Number : FSCECOII-354

Device Description : DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureCOC/mAMP/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006613 Catalog Number : FSCECOII-654

Device Description : DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureBZO/COC/mAMP/OPI/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006620 Catalog Number : FSCECOII-4254

Device Description : DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for HemosureAMP/BZO/COC/mAMP/OPI

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006637 Catalog Number : FSCECOII-564

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00857338006644 Catalog Number : FSCECOII-3464

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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