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

Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Amphetamine (DKZ) (9) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Phencyclidine (LCM) (8) Gas Chromatography, Methamphetamine (LAF) (6) Enzyme Immunoassay, Methadone (DJR) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Enzyme Immunoassay, Barbiturate (DIS) (4) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (3) Test, Cannabinoid, Over The Counter (NFW) (3) Test, Opiates, Over The Counter (NGL) (3) Test, Methamphetamine, Over The Counter (NGG) (2) Test, Amphetamine, Over The Counter (NFT) (2) Enzyme Immunoassay, Propoxyphene (JXN) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1)

Premarket Exempt

No Yes

Clear

ImmuTest Drugs of Abuse Cup - 00816565020298 Catalog Number : IMCA-12BUP

Device Description : 12 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BU 12 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020304 Catalog Number : IMCA-13M

Device Description : 13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(P 13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP1000)+BUP with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020311 Catalog Number : IMCA-11OP

Device Description : 11 panel test cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(PCP/AMP)+MTD+OXY+PPX with Cr, 11 panel test cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(PCP/AMP)+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020328 Catalog Number : IMCA-9A

Device Description : 9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, 9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020335 Catalog Number : IMCA-9CM5

Device Description : 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, N 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020342 Catalog Number : IMCA-9CM5-5

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020359 Catalog Number : IMCA-10M5

Device Description : 10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with 10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020502 Catalog Number : C-C0501A-3A

Device Description : THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DKZ, NFT, NFY, NGL, NFW, LDJ, DIO, DJG, LCM

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020519 Catalog Number : C-C0502A-3A

Device Description : THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : LCM, NGG, DJC, DJG, DIO, LDJ, NFW, NGL, NFY

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020526 Catalog Number : C-C0503A-3A

Device Description : THC, COC, OPI, AMP, MET with Adulteration Screen for OX/SG/PH

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : NFY, NFT, NGL, NFW, LDJ, DKZ, DIO, DJG, DJC, NGG

Prescription Use : Yes

Device Count : 1

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