PRINCETON BIOMEDITECH CORPORATION

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

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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

Thin Layer Chromatography, Methamphetamine (DJC) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Enzyme Immunoassay, Opiates (DJG) (2) Enzyme Immunoassay, Amphetamine (DKZ) (1)

Premarket Exempt

No Yes

Clear

AccuSign® COC card - 10743816000013 Catalog Number : DOA-200-35-02

Device Description : AccuSign® COC card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

AccuSign® COC card - 10743816000020 Catalog Number : DOA-200-10-02

Device Description : AccuSign® COC card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

AccuSign® THC card - 10743816000037 Catalog Number : DOA-201-35-02

Device Description : AccuSign® THC card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LDJ

Prescription Use : No

Device Count : 1

AccuSign® THC card - 10743816000044 Catalog Number : DOA-201-10-02

Device Description : AccuSign® THC card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LDJ

Prescription Use : No

Device Count : 1

AccuSign® MET card - 10743816000051 Catalog Number : DOA-202-35-02

Device Description : AccuSign® MET card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJC

Prescription Use : No

Device Count : 1

AccuSign® MET card - 10743816000068 Catalog Number : DOA-202-10-02

Device Description : AccuSign® MET card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJC

Prescription Use : No

Device Count : 1

AccuSign® MET 500 card - 10743816000075 Catalog Number : DOA-202E-35-00

Device Description : AccuSign® MET 500 card; 35 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJC

Prescription Use : No

Device Count : 1

AccuSign® OPI card - 10743816000082 Catalog Number : DOA-203-35-02

Device Description : AccuSign® OPI card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

AccuSign® OPI card - 10743816000099 Catalog Number : DOA-203-10-02

Device Description : AccuSign® OPI card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 1

AccuSign® AMP card - 10743816000105 Catalog Number : DOA-204-35-02

Device Description : AccuSign® AMP card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DKZ

Prescription Use : No

Device Count : 1

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