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, Phencyclidine (LCM) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Benzodiazepine (JXM) (9) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Cannabinoids (LDJ) (9) Enzyme Immunoassay, Amphetamine (DKZ) (9) Thin Layer Chromatography, Morphine (DNK) (8) Enzyme Immunoassay, Barbiturate (DIS) (8) Enzyme Immunoassay, Opiates (DJG) (8) Enzyme Immunoassay, Methadone (DJR) (6) Enzyme Immunoassay, Propoxyphene (JXN) (5) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4) Gas Chromatography, Methamphetamine (LAF) (1)

Premarket Exempt

Clear

Premier Biotech - 00812203030315 Catalog Number :

Device Description : 14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Generic - 00812203030322 Catalog Number :

Device Description : 11-Panel Drug Screen Dip - AMP/BAR/BZO/COC/MET/MDMA/MOR/MTD/OXY/PCP/TCA

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030353 Catalog Number :

Device Description : 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (C 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030360 Catalog Number : PCA-10X3S-LC

Device Description : Premier Biotech 10-Panel DOA Cup, AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI3 Premier Biotech 10-Panel DOA Cup, AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/THC50(Cr/Ox/pH

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

OSTS - 00812203030377 Catalog Number :

Device Description : OSTS 11-Panel DOA Dip Test AMP500/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR/OXY/PCP

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Chemtrue - 00812203030483 Catalog Number :

Device Description : 7-Panel Chemtrue DOA Cup, AMP/COC/MET500/OPI300/OXY/PCP/THC + (Cr/SG/Ox)(Ni/pH/Gl)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030490 Catalog Number :

Device Description : 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (O 12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Premier Biotech - 00812203030506 Catalog Number :

Device Description : 10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Chemtrue - 00812203030513 Catalog Number :

Device Description : Chemtrue 7-Panel DOA Dip Card, BZO/COC150/MET500/MOR/OXY/PCP/THC (Ni/pH/Gl)(Cr/SG/Ox)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

Product Code : LDJ, LCM, DJC, DIO, JXM, DNK, DJG

Prescription Use : Yes

Device Count : 1

Chemtrue - 00812203030520 Catalog Number :

Device Description : Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/ Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/THC + A-strip (Cr/Ox/pH)

Device Class : 2

Duns Number: 795658603

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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