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 - 00816490020301 Catalog Number : HDTH-101

Device Description : Single Panel DOA Test Strip

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 - 00816490020318 Catalog Number : HDOP-201

Device Description : Single Panel DOA Test Cassette

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 - 00816490020325 Catalog Number : HDOA-565

Device Description : 6 Panel DOA Test Dipcard

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020332 Catalog Number : HDBU-201

Device Description : Single Panel DOA Test Cassette

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020349 Catalog Number : HDOP-101

Device Description : Single Panel DOA Test Strip

Device Class : 2

Duns Number: 031802328

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Healgen - 00816490020356 Catalog Number : HDCO-101

Device Description : Single Panel DOA Test Strip

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 - 00816490020363 Catalog Number : HDOA-424

Device Description : 2 Panel DOA Test Dipcard

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 - 00816490020370 Catalog Number : HDOA-134

Device Description : 3 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 - 00816490020387 Catalog Number : HDOA-234

Device Description : 3 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 - 00816490020394 Catalog Number : HDOA-144

Device Description : 4 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

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