ALFA SCIENTIFIC DESIGNS, INC.

Address:13200 GREGG ST.,POWAY,CA,92064,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

Thin Layer Chromatography, Methamphetamine (DJC) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Reagents, Test, Tetrahydrocannabinol (DKE) (2) Enzyme Immunoassay, Amphetamine (DKZ) (2) Enzyme Immunoassay, Phencyclidine (LCM) (2) Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. (DOE) (2) Reagent, Occult Blood (KHE) (2) Enzyme Immunoassay, Methadone (DJR) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1)

Premarket Exempt

Clear

INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300 - 10796918002423 Catalog Number :

Device Description : INSTANT-VIEW Multi-Drugs of Abuse Urine TestAMP, BZD, COC, MET, MOR300, MTD,OPI2 INSTANT-VIEW Multi-Drugs of Abuse Urine TestAMP, BZD, COC, MET, MOR300, MTD,OPI2000, PCP, TCA, THC

Device Class : 2

Duns Number: 176391167

Premarket Exempt : No

Product Code : DKE, LFG, LCM, DJR, DOE, DJC, DIO, JXM, DKZ

Prescription Use : No

Device Count : 20

Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THC - 10796918002430 Catalog Number :

Device Description : Instant-View Multi-Drug of Abuse Urine Cup TestAMP BZD COC MET MOR/OPI PCP THC

Device Class : 2

Duns Number: 176391167

Premarket Exempt : No

Product Code : DKZ, DIO, DJC, DOE, LCM, DKE, JXM

Prescription Use : No

Device Count : 25

INSTANT-VIEW FOB Test - complete kit, 25 test - 20796918001904 Catalog Number :

Device Description : INSTANT-VIEW FOB TestFecal Occult Blood – Cassette with mailer25 tests

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 25

INSTANT-VIEW FOB Test - complete kit, 50 test - 30796918001901 Catalog Number :

Device Description : INSTANT-VIEW FOB TestFecal Occult Blood – Cassette with mailer50 tests

Device Class :

Duns Number: 176391167

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 50

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