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) (7) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Enzyme Immunoassay, Amphetamine (DKZ) (5) Gas Chromatography, Methamphetamine (LAF) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4) Enzyme Immunoassay, Methadone (DJR) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Phencyclidine (LCM) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Reagent, Occult Blood (KHE) (2)

Premarket Exempt

No Yes

Clear

FIRST SIGN® - 00817763021704 Catalog Number : FSCDIP134

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : LFG, DJG, DIO

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021711 Catalog Number : FSCDIP234

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : LAF, DIO, LFG

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021759 Catalog Number : FSCDIP234

Device Description : DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/ DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/MOR/OXY

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : JXM, DJG, DKZ, DIO

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021773 Catalog Number : FSCDIPOX-25

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

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 25

HEMOSURE® - 00817763021797 Catalog Number : T1-CK50US

Device Description : Hemosure FOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Maile Hemosure FOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer (Made in USA)

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021803 Catalog Number : FSCDIP47104

Device Description : DOA 10 in 1 Test Dip Card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BU DOA 10 in 1 Test Dip Card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

FIRST SIGN® - 00817763021827 Catalog Number : FSCCUP-22114

Device Description : DOA 11 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZ DOA 11 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/TCA

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : LDJ, LFG, LAF, DJR, DIS, JXM, DKZ, DJG, DIO, LCM

Prescription Use : Yes

Device Count : 25

HEMOSURE® - 00817763021841 Catalog Number : T1-TB100L

Device Description : Hemosure FOB Buffer Tube Plain Box Set (100 Purple Cap Tubes with Long Labels)

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 100

FIRST SIGN® - 00817763021858 Catalog Number : FSCCUP-14124-B300

Device Description : DOA 12 in 1 Test Cup, 25Pcs/Box without Box Label on Each Box; 12Boxes/Case; Fir DOA 12 in 1 Test Cup, 25Pcs/Box without Box Label on Each Box; 12Boxes/Case; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : LCM, DIO, DJG, DKZ, JXM, DIS, DJR, LAF, LFG, LDJ

Prescription Use : Yes

Device Count : 300

FIRST SIGN® - 00817763021872 Catalog Number : FSCCUP-6264

Device Description : DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/ DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedAMP/BUP/BZO/COC/MOR/OXY

Device Class :

Duns Number: 806777541

Premarket Exempt : No

Product Code : DIO, DKZ, DJG, JXM

Prescription Use : Yes

Device Count : 25

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