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

Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (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) Enzyme Immunoassay, Amphetamine (DKZ) (10) Gas Chromatography, Methamphetamine (LAF) (10) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

Clear

Healgen - 00816490020608 Catalog Number : HDOA-3104

Device Description : 10 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020615 Catalog Number : HDOA-4104

Device Description : 10 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020622 Catalog Number : HDOA-7104

Device Description : 10 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020639 Catalog Number : HDOA-1124

Device Description : 12 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020646 Catalog Number : HDOA-6125

Device Description : 12 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020653 Catalog Number : HDOA-5125

Device Description : 12 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020660 Catalog Number : HDOA-6124

Device Description : 12 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020677 Catalog Number : HDOA-6124A3

Device Description : 12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020684 Catalog Number : HDOA-274

Device Description : 7 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020691 Catalog Number : HCDOAF-254A3

Device Description : 5 Panel DOA Test Clear Flat Cup + Adulterant Test StripsOXI/SG/pH

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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