BIOTECH SCREENING LLC

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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, Amphetamine (DKZ) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Opiates (DJG) (4) Gas Chromatography, Methamphetamine (LAF) (4) Enzyme Immunoassay, Cannabinoids (LDJ) (3)

Premarket Exempt

Clear

BioTech Screening - 00863112000302 Catalog Number : CI-565

Device Description : 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY

Device Class :

Duns Number: 962374968

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

BioTech Screening - 00863112000319 Catalog Number : CINM-274

Device Description : 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC

Device Class :

Duns Number: 962374968

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

BioTech Screening - 00863112000326 Catalog Number : CINM-774

Device Description : 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC

Device Class :

Duns Number: 962374968

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

BioTech Screening - 00863112000364 Catalog Number : CI-575

Device Description : 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC

Device Class : 2

Duns Number: 962374968

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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