PRINCETON BIOMEDITECH CORPORATION

Address:4242 U.S. Hwy. 1,Monmouth Jct,NJ,08852,US

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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, Opiates (DJG) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Phencyclidine (LCM) (7) Thin Layer Chromatography, Methamphetamine (DJC) (6) Enzyme Immunoassay, Amphetamine (DKZ) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (MLK) (2)

Premarket Exempt

Yes No

Clear

AccuSign® DOA 4/MET card - 10743816000327 Catalog Number : DOA-241-10-02

Device Description : AccuSign® DOA 4 TH/O/C/ME card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LDJ, DJG, DIO, DJC

Prescription Use : No

Device Count : 1

Status DS™ 4/MET stick - 10743816000334 Catalog Number : DOA-141-35-00

Device Description : Status DS™ TH/O/C/ME stick; 35 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJC, DIO, DJG, LDJ

Prescription Use : No

Device Count : 1

Status DS™ 4/MET stick - 10743816000341 Catalog Number : DOA-141-10-00

Device Description : Status DS™ TH/O/C/ME stick; 10 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LDJ, DJC, DIO, DJG

Prescription Use : No

Device Count : 1

AccuSign® DOA 5/AMP card - 10743816000358 Catalog Number : DOA-250-35-02

Device Description : AccuSign® DOA 5 A/O/C/TH/P card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LCM, DIO, DKZ, DJG, LDJ

Prescription Use : No

Device Count : 1

AccuSign® DOA 5/AMP card - 10743816000365 Catalog Number : DOA-250-10-01

Device Description : AccuSign® DOA 5 A/O/C/TH/P card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LCM, DIO, DKZ, DJG, LDJ

Prescription Use : No

Device Count : 1

AccuSign® DOA 5/MET card - 10743816000372 Catalog Number : DOA-251-35-02

Device Description : AccuSign® DOA 5 ME/O/C/TH/P card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LCM, DIO, DJC, LDJ, DJG

Prescription Use : No

Device Count : 1

AccuSign® DOA 5/MET card - 10743816000389 Catalog Number : DOA-251-10-02

Device Description : AccuSign® DOA 5 ME/O/C/TH/P card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJC, DJG, LDJ, LCM, DIO

Prescription Use : No

Device Count : 1

StatusFirst™ 5/MET card - 10743816000396 Catalog Number : DOA-251-25-02

Device Description : StatusFirst™ ME/O(2K)/C/TH/P card; 25 Test kit; for reader

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LCM, DIO, DJC, DJG, LDJ

Prescription Use : No

Device Count : 1

Status DS™ 8 card - 10743816000433 Catalog Number : DOA-280-25-01

Device Description : Status DS™ T/O/C/A//BZ/BA/TC/P card; 25 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JXM, DJG, LCM, DKZ, DIS, DIO, MLK, LDJ

Prescription Use : No

Device Count : 1

Status DS™ 8 card - 10743816000440 Catalog Number : DOA-280-10-01

Device Description : Status DS™ T/O/C/A//BZ/BA/TC/P card; 10 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LCM, DKZ, JXM, DJG, DIS, DIO, LDJ, MLK

Prescription Use : No

Device Count : 1

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