CORETESTS, INC.

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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

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (2) Enzyme Immunoassay, Amphetamine (DKZ) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Opiates (DJG) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

Clear

ACCU NEWS Pregnancy Test Midstream - 00850042559000 Catalog Number :

Device Description : 3 pcs/box

Device Class : 2

Duns Number: 036440919

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

ACCU NEWS Ovulation Test + Pregnancy Test Combo - 00850042559017 Catalog Number :

Device Description : 70 pcs/box

Device Class : 2

Duns Number: 036440919

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

ACCU NEWS Multi-Drug Screen Test - 00850042559024 Catalog Number :

Device Description : 5 pcs/box

Device Class : 2

Duns Number: 036440919

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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