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 - 00816490020202 Catalog Number : HDBA-114

Device Description : Single 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 - 00816490020219 Catalog Number : HDBU-114

Device Description : Single 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 - 00816490020226 Catalog Number : HDBZ-114

Device Description : Single 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 - 00816490020233 Catalog Number : HDCO-114

Device Description : Single 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 - 00816490020240 Catalog Number : HDOA-664

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 - 00816490020257 Catalog Number : HDOA-675H

Device Description : 7 Panel DOA Test Dipcard

Device Class :

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 - 00816490020264 Catalog Number : HDOA-124

Device Description : 2 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 - 00816490020271 Catalog Number : HDTH-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 - 00816490020288 Catalog Number : HDOX-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 - 00816490020295 Catalog Number : HDCO-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

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