AMEDITECH INC.

Address:9940 Mesa Rim Rd,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

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Test, Amphetamine, Employment And Insurance Testing, Exempt (PUX) (1) Test, Barbiturate, Employment And Insurance Testing, Exempt (PUY) (1) Test, Benzodiazepine, Employment And Insurance Testing, Exempt (PUZ) (1) Test, Cannabinoid, Employment And Insurance Testing, Exempt (PVJ) (1) Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt (PVA) (1) Test, Methadone, Employment And Insurance Testing, Exempt (PVE) (1) Test, Methamphetamine, Employment And Insurance Testing, Exempt (PVD) (1) Test, Opiates, Employment And Insurance Testing, Exempt (PVH) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

No Yes

Clear

QuickTox Drug Screen Dipcard - 00816565021523 Catalog Number : QT88A

Device Description : COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500/BUP COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500/BUP10 with Ni, Gl, Cr, pH, S.G., OX

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

eCUP + Drug Screening Device - 00816565021530 Catalog Number : 94615

Device Description : 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adultera 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni

Device Class : 2

Duns Number: 010551716

Premarket Exempt : Yes

Product Code : PVA, PVH, PUZ, PUY, PVD, PUX, PVE, PVJ

Prescription Use : No

Device Count : 1

eREADER+ Drug Screening Instrument - 00816565021547 Catalog Number :

Device Description : ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni.

Device Class : 1

Duns Number: 010551716

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : No

Device Count : 1

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