CHEMTRON BIOTECH INC

Address:9245 Brown Deer Rd Ste B,San Diego,CA,92121,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) (9) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Amphetamine (DKZ) (9) Enzyme Immunoassay, Opiates (DJG) (8) Enzyme Immunoassay, Phencyclidine (LCM) (8) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Gas Chromatography, Methamphetamine (LAF) (3) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Thin Layer Chromatography, Morphine (DNK) (2) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

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Chemtrue - 00812203030551 Catalog Number :

Device Description : Chemtrue 5-Panel DOA Cup, AMP500/COC150/MET500/OPI/PCP/(Cr/SG/Ox/Ni/pH/Gl)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030568 Catalog Number :

Device Description : 10 Panel Cup W/ AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/ 10 Panel Cup W/ AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/(Cr/Ox/pH)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030575 Catalog Number :

Device Description : 6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030582 Catalog Number :

Device Description : 6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

DrugSmart Cup 9 - 00812203030605 Catalog Number :

Device Description : DrugSmart Cup 9 CLIA-Waived, AMP/COC/OPI2K/MET/PCP/BAR/BZO/PPX/MTD, 25tests/kit

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

OSTS - 00850019007008 Catalog Number : 712L01OS

Device Description : OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/ PCP/THC, 25pcs/kit

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Chemtrue - 00850019007015 Catalog Number : 712L01CT

Device Description : Chemtrue® 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR30 Chemtrue® 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

OSTS - 00850019007022 Catalog Number : 711L02OS

Device Description : OSTS 12-Panel Drug Screen Dip Card Tests COC/MOR300/MET/THC/AMP/PCP/BZO/BAR/ MTD OSTS 12-Panel Drug Screen Dip Card Tests COC/MOR300/MET/THC/AMP/PCP/BZO/BAR/ MTD/OXY/MDMA/BUP, 25pcs/kit

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

N/A - 00850019007039 Catalog Number : 712F01

Device Description : 6-Panel Drug Screen Cup Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

DrugSmart Dip - 00850019007046 Catalog Number : 30180D

Device Description : DrugSmart Dip 1 BUP, 25pcs/kit

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

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