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

Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (7) Enzyme Immunoassay, Cannabinoids (LDJ) (7) Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassasy, Nocotine And Nicotine Metabolites (MKU) (2) Enzyme Immunoassay, Amphetamine (DKZ) (2) Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (MLK) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

No Yes

Clear

AccuSign® TCA card - 10743816000211 Catalog Number : DOA-209-10-02

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

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : MLK

Prescription Use : No

Device Count : 1

AccuSign® Nicotine card - 10743816000235 Catalog Number : DOA-217-35-00

Device Description : AccuSign® Nicotine card; 35 Test Kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : MKU

Prescription Use : No

Device Count : 1

Status™ Nicotine card - 10743816000242 Catalog Number : DOA-217-35-01

Device Description : Status Nicotine™ card; 35 Test Kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : MKU

Prescription Use : No

Device Count : 1

AccuSign® DOA 2 THC/COC card - 10743816000259 Catalog Number : DOA-221-35-02

Device Description : AccuSign® DOA 2 THC/COC card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LDJ, DIO

Prescription Use : No

Device Count : 1

AccuSign® DOA 2 THC/COC card - 10743816000266 Catalog Number : DOA-221-10-02

Device Description : AccuSign® DOA 2 THC/COC card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DIO, LDJ

Prescription Use : No

Device Count : 1

AccuSign® DOA 3 TH/O/C card - 10743816000273 Catalog Number : DOA-230-35-02

Device Description : AccuSign® DOA 3 TH/O/C card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJG, LDJ, DIO

Prescription Use : No

Device Count : 1

AccuSign® DOA 3 TH/O/C card - 10743816000280 Catalog Number : DOA-230-10-02

Device Description : AccuSign® DOA 3 TH/O/C card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJG, LDJ, DIO

Prescription Use : No

Device Count : 1

AccuSign® DOA 4/AMP card - 10743816000297 Catalog Number : DOA-240-35-02

Device Description : AccuSign® DOA 4 TH/O/C/A card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DKZ, DJG, LDJ, DIO

Prescription Use : No

Device Count : 1

AccuSign® DOA 4/AMP card - 10743816000303 Catalog Number : DOA-240-10-02

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

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DKZ, DJG, LDJ, DIO

Prescription Use : No

Device Count : 1

AccuSign® DOA 4/MET card - 10743816000310 Catalog Number : DOA-241-35-02

Device Description : AccuSign® DOA 4 TH/O/C/ME card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DJG, DJC, LDJ, DIO

Prescription Use : No

Device Count : 1

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