Healgen Scientific Limited Liability Company

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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

Enzyme Immunoassay, Amphetamine (DKZ) (10) Enzyme Immunoassay, Barbiturate (DIS) (10) Enzyme Immunoassay, Benzodiazepine (JXM) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Methadone (DJR) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Phencyclidine (LCM) (10) Gas Chromatography, Methamphetamine (LAF) (10) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (10)

Premarket Exempt

Clear

Healgen - 00816490020813 Catalog Number : HCDOAV-5125

Device Description : 12 Panel DOA Test clear Round Cup With Clicker;

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020820 Catalog Number : HCDOAV-5125A3

Device Description : 12 Panel DOA Test clear Round Cup With Clicker + 3 Adulterant Test Strips OXI/SG/pH

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020837 Catalog Number : HCDOAV-254

Device Description : 5 Panel DOA Test Clear Round Cup With Clicker

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020844 Catalog Number : HCDOAV-254A3

Device Description : 5 Panel DOA Test Clear Round Cup +3 Adulterant Test Strips OXI/SG/pH

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020851 Catalog Number : HCDOAV-255

Device Description : 5 Panel DOA Test clear Round Cup With Clicker

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020868 Catalog Number : HCDOAV-564

Device Description : 6 Panel DOA Test clear Round Cup With Clicker

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020875 Catalog Number : HCDOAV-274

Device Description : 12 Panel DOA Test clear Round Cup With Clicker

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020882 Catalog Number : HCDOAV-274A3

Device Description : 7 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020899 Catalog Number : HCDOAV-164

Device Description : 6 Panel DOA Test clear Round Cup With Clicker

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020905 Catalog Number : HCDOAV-264

Device Description : 6 Panel DOA Test clear Round Cup With Clicker

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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