PREMIER BIOTECH, INC

Address:725 Kasota Ave SE,Minneapolis,MN,55414,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, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Amphetamine (DKZ) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Enzyme Immunoassay, Methadone (DJR) (9) Enzyme Immunoassay, Phencyclidine (LCM) (8) Enzyme Immunoassay, Barbiturate (DIS) (7) Enzyme Immunoassay, Propoxyphene (JXN) (3) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1)

Premarket Exempt

Clear

Premier Bio-Cup & Bio-Dip - B313PBCUP10041 Catalog Number : PBCup-10-04

Device Description : AMP1000/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP10061 Catalog Number : PBCup-10-06

Device Description : AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/PPX300/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP10201 Catalog Number : PBCup-10-20

Device Description : AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP10321 Catalog Number : PBCup-10-32

Device Description : AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP10331 Catalog Number : PBCup-10-33

Device Description : AMP500/BAR300/BZO300/COC150/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP12021 Catalog Number : PBCup-12-02

Device Description : AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP12191 Catalog Number : PBCup-12-19

Device Description : AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUP13011 Catalog Number : PBCup-13-01

Device Description : AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUPA05021 Catalog Number : PBCupA-05-02

Device Description : AMP500/COC150/MET500/OPI300/THC50/(OX/pH/SG)

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

Premier Bio-Cup & Bio-Dip - B313PBCUPA09061 Catalog Number : PBCupA-09-06

Device Description : AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)

Device Class :

Duns Number: 010118759

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

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