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) (9) Enzyme Immunoassay, Opiates (DJG) (8) Enzyme Immunoassay, Amphetamine (DKZ) (6) Reagents, Test, Tetrahydrocannabinol (DKE) (6) Thin Layer Chromatography, Methamphetamine (DJC) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763020462 Catalog Number : FSCDIP1424

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJG, DJC

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020479 Catalog Number : FSCDIP334

Device Description : DOA 3 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DKZ, DIO, DKE

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020486 Catalog Number : FSCDIP1634

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DIO, DJC, JXM

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020493 Catalog Number : FSCCUP-154

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020509 Catalog Number : FSCCUP-254

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020516 Catalog Number : FSCCUP-354

Device Description : DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedCOC/mAMP/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020523 Catalog Number : FSCCUP-654

Device Description : DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/COC/mAMP/OPI/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020530 Catalog Number : FSCCUP-4254

Device Description : DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO/COC/mAMP/OPI

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020547 Catalog Number : FSCCUP-4854

Device Description : DOA 5 in 1 Test Cup, 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, LDJ

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020554 Catalog Number : FSCDIP154

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/OPI/PCP/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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