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) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Thin Layer Chromatography, Methamphetamine (DJC) (9) Reagents, Test, Tetrahydrocannabinol (DKE) (9) Enzyme Immunoassay, Amphetamine (DKZ) (8) Enzyme Immunoassay, Phencyclidine (LCM) (3) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763020660 Catalog Number : FSCCUP-264 W/AD2

Device Description : DOA 6 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZ DOA 6 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO/COC/mAMP/OPI/THC/PH-SG-CR

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020677 Catalog Number : FSCDIP264

Device Description : DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZ DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/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® - 00817763020684 Catalog Number : FSCDIP564

Device Description : DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/CO DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedBZO/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® - 00817763020691 Catalog Number : FSCDIP3464

Device Description : DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/COC DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/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

FIRST SIGN® - 00817763020707 Catalog Number : FSCDIP1664

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : LDJ, DJR, JXM, DIO, DJG

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020714 Catalog Number : FSCCUP-174

Device Description : DOA 7 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO/COC/ DOA 7 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO/COC/mAMP/OPI/OXY/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® - 00817763020721 Catalog Number : FSCCUP-874

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763020738 Catalog Number : FSCCUP-2974

Device Description : DOA 7 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/ DOA 7 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/mAMP/MOR/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® - 00817763020745 Catalog Number : FSCDIP174

Device Description : DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BZO DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/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® - 00817763020752 Catalog Number : FSCDIP874

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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