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, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Opiates (DJG) (9) Enzyme Immunoassay, Amphetamine (DKZ) (7) Thin Layer Chromatography, Methamphetamine (DJC) (7) Reagents, Test, Tetrahydrocannabinol (DKE) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Methadone (DJR) (3) Enzyme Immunoassay, Phencyclidine (LCM) (2) Antimicrobial Medical Glove (OPI) (1) Gas Chromatography, Methamphetamine (LAF) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Barbiturate (DIS) (1)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763020561 Catalog Number : FSCDIP254

Device Description : DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/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® - 00817763020578 Catalog Number : FSCDIP354

Device Description : DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedCOC/mAM DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedCOC/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® - 00817763020585 Catalog Number : FSCDIP654

Device Description : DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/COC DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/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® - 00817763020592 Catalog Number : FSCDIP4254

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/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® - 00817763020608 Catalog Number : FSCDIP4854

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020615 Catalog Number : FSCCUP-264

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020622 Catalog Number : FSCCUP-564

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020639 Catalog Number : FSCCUP-3464

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020646 Catalog Number : FSCCUP-5764

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020653 Catalog Number : FSCDIP5964

Device Description : DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC/ DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC/MTD/OPI/OXY/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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