AMEDITECH INC.

Address:9940 Mesa Rim Rd,SAN DIEGO,CA,92121,US

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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

Test, Opiates, Over The Counter (NGL) (10) Enzyme Immunoassay, Opiates (DJG) (10) Test, Amphetamine, Over The Counter (NFT) (10) Test, Methamphetamine, Over The Counter (NGG) (10) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (10) Test, Benzodiazepine, Over The Counter (NFV) (9) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Amphetamine (DKZ) (7) Enzyme Immunoassay, Barbiturate (DIS) (7) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Enzyme Immunoassay, Methadone (DJR) (7) Test, Cannabinoid, Over The Counter (NFW) (6) Enzyme Immunoassay, Phencyclidine (LCM) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (5) Enzyme Immunoassay, Cannabinoids (LDJ) (5)

Premarket Exempt

No Yes

Clear

AmediCheck Instant Test Cup - 00816565020533 Catalog Number : C-C0601A-3A

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

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020540 Catalog Number : C-C0611A-3A

Device Description : COC, OPI300, AMP, MET, BZO, OXY with Adulteration Screen for OX/SG/PH

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : JXM, DKZ, DIO, DJG, NFV, DJC, NGG, NFY, NFT, NGL

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020557 Catalog Number : C-C1012A-3A

Device Description : THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : NGL, NFT, NFY, NGG, DJC, DIS, NFV, DJR, DJG, DIO, DKZ, JXM, NFW, LDJ

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020564 Catalog Number : C-C1016A

Device Description : THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : LDJ, NFW, JXM, DKZ, DIO, DJG, DJR, NFV, DIS, DJC, NGG, NFT, NGL, NFY

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020571 Catalog Number : C-C1102A

Device Description : COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : NFY, NGL, NFT, NGG, LCM, DJC, DIS, NFV, DJR, LFG, DJG, DIO, DKZ, JXM

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020588 Catalog Number : C-C1202A

Device Description : THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : JXM, DKZ, DIO, DJG, LFG, DJR, NFV, DIS, DJC, LCM, NGG, NFT, NGL, NFY, NFW, LDJ

Prescription Use : Yes

Device Count : 1

AmediCheck Instant Test Cup - 00816565020595 Catalog Number : C-60B02

Device Description : THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DJC, LDJ, NFW, NFY, NGL, NFT, NGG, LCM, DIS, NFV, DJR, LFG, DJG, DIO, DKZ, JXM

Prescription Use : Yes

Device Count : 1

Instant Test Cup - 00816565020601 Catalog Number : 10-100

Device Description : THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 Drugs of Abuse Test Cup (CLIA WAIVED)

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DJG, LFG, DJR, NFV, DIS, DJC, LCM, NGG, NFT, NGL, NFY, NFW

Prescription Use : No

Device Count : 1

Instant Test Cup - 00816565020618 Catalog Number : 10-200

Device Description : COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA100 COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED)

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : NFY, NGL, NFT, NGG, LCM, DJC, DIS, NFV, DJR, LFG, DJG

Prescription Use : No

Device Count : 1

Instant Test Cup - 00816565020625 Catalog Number : 10-300

Device Description : COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drug COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED)

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DJG, NFV, NGG, NFT, NGL, NFY

Prescription Use : No

Device Count : 1

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