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, Opiates (DJG) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (9) Enzyme Immunoassay, Amphetamine (DKZ) (8) Enzyme Immunoassay, Benzodiazepine (JXM) (5) Thin Layer Chromatography, Methamphetamine (DJC) (4) Enzyme Immunoassay, Phencyclidine (LCM) (4) Enzyme Immunoassay, Methadone (DJR) (3) Enzyme Immunoassay, Barbiturate (DIS) (2) Gas Chromatography, Methamphetamine (LAF) (1)

Premarket Exempt

No Yes

Clear

ImmuTest Drugs of Abuse Cup - 00816565020199 Catalog Number : IMCA-3P

Device Description : 3 panel test cup, COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : LDJ, DJG, DIO

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020205 Catalog Number : IMCA-5AB-W

Device Description : 5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration 5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020212 Catalog Number : IMCA-5BO3

Device Description : 5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50 with Cr, Ni, pH, Bl, S.G. ad 5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : LDJ, DJG, DJR, DIO, JXM

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of abuse Cup - 00816565020229 Catalog Number : IMCA-5M

Device Description : 5 panel test cup, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020236 Catalog Number : IMCA-5P

Device Description : 5 panel test cup, AMP/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020243 Catalog Number : IMCA-7MT-W

Device Description : 7 panel test cup, AMP/BAR/BZO/COC/MTD/OPI2000/OXY with Cr, Ni, pH, Bl, S.G. adul 7 panel test cup, AMP/BAR/BZO/COC/MTD/OPI2000/OXY with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

Product Code : DJG, DJR, DIO, JXM, DIS, DKZ

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020250 Catalog Number : IMCA-7P

Device Description : 7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adul 7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020267 Catalog Number : IMCA-8BB

Device Description : 8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, 8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020274 Catalog Number : IMCA-6C1M5P

Device Description : 6 panel test cup, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, 6 panel test cup, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests

Device Class : 2

Duns Number: 010551716

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ImmuTest Drugs of Abuse Cup - 00816565020281 Catalog Number : IMCA-8CM5

Device Description : 8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni 8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+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

Prescription Use : Yes

Device Count : 1

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