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 - 00816490020400 Catalog Number : HDOA-154

Device Description : 5 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 - 00816490020417 Catalog Number : HDOA-154A3

Device Description : 5 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 - 00816490020424 Catalog Number : HDOA-254

Device Description : 5 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 - 00816490020431 Catalog Number : HDOA-254A3

Device Description : 5 Panel DOA Test Dipcard +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

Healgen - 00816490020448 Catalog Number : HDOA-254K

Device Description : 5 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 - 00816490020455 Catalog Number : HDOA-255

Device Description : 5 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 - 00816490020462 Catalog Number : HDOA-354

Device Description : 5 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 - 00816490020479 Catalog Number : HDOA-554

Device Description : 5 Panel DOA Test Dipcard

Device Class :

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 - 00816490020486 Catalog Number : HDOA-654

Device Description : 5 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 - 00816490020493 Catalog Number : HDOA-654A3

Device Description : 5 Panel DOA Test Dipcard +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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