IDUN SOLUTIONS LLC

Address:340 S LEMON AVE #3488,Walnut,CA,91789,US

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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, Amphetamine (DKZ) (7) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Thin Layer Chromatography, Morphine (DNK) (7) Thin Layer Chromatography, Methamphetamine (DJC) (6) Enzyme Immunoassay, Phencyclidine (LCM) (6) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Enzyme Immunoassay, Methadone (DJR) (4) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (2) Radioimmunoassay, Luteinizing Hormone (CEP) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1)

Premarket Exempt

No Yes

Clear

PreChek - 00857275007520 Catalog Number :

Device Description : 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP30 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10)

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : DJR, DJC, DIS, JXM, DNK, LCM, LDJ, DJG, DIO, DKZ

Prescription Use : Yes

Device Count : 1

PreKnow - 00857275007537 Catalog Number :

Device Description : 5 Multi Drug Test Panel (AMP 1000 • COC 300 • MET 1000 • OPI 2000 • THC 50)

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : LDJ, DJC, DIO, DKZ, DNK

Prescription Use : Yes

Device Count : 1

PreKnow - 00857275007544 Catalog Number :

Device Description : HCG Pregnancy Test Strip -3.5mm

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

PreKnow - 00857275007551 Catalog Number :

Device Description : LH Ovulation Test Strip-3.5mm

Device Class : 1

Duns Number: 080651010

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

PreKnow - 00857275007568 Catalog Number :

Device Description : 5 Multi Drug Test Panel ( AMP1000 • COC 300 • OPI2000 •THC 50 • PCP25)

Device Class :

Duns Number: 080651010

Premarket Exempt : No

Product Code : LCM, LDJ, DNK, DIO, DKZ

Prescription Use : Yes

Device Count : 1

PreChek - 00857275007575 Catalog Number :

Device Description : 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300• TCA1000)

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

PreKnow - 00857275007735 Catalog Number :

Device Description : HCG Pregnancy Test Strip-3.5mm

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

N/M - 00857275007797 Catalog Number :

Device Description : 12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP)

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : LDJ, DIO, DNK, DKZ, DJC, LCM, DIS, JXM, DJR, DJG

Prescription Use : No

Device Count : 1

N/M - 90857275007813 Catalog Number :

Device Description : 25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : DJG, DJR, JXM, DIS, LCM, DJC, DKZ, DNK, DIO, LDJ

Prescription Use : No

Device Count : 1

Wholepower - 90857275007837 Catalog Number :

Device Description : 10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)

Device Class : 2

Duns Number: 080651010

Premarket Exempt : No

Product Code : LCM, DIO, JXM, DIS, DKZ, DJG, DNK, DJC

Prescription Use : No

Device Count : 1

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