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

Reagent, Occult Blood (KHE) (4) Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (2) System, Test, Infectious Mononucleosis (KTN) (1)

Premarket Exempt

Yes No

Clear

BioSign Mono card - 10743816000983 Catalog Number : BSP-402WB-25-06

Device Description : BioSign Mono card; 25 Test kit (for LifeSign)

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 1

StatusFirst Mono controls - 10743816001010 Catalog Number : BSP-402C-00

Device Description : StatusFirst Mono Pos/Neg controls (2 x 1 mL)

Device Class :

Duns Number: 362917692

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

BioSign® Rubella card - 10743816001027 Catalog Number : BSP-171-35-01

Device Description : BioSign® Rubella card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

BioSign® Rubella card - 10743816001034 Catalog Number : BSP-171-10-01

Device Description : BioSign® Rubella card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

BioSign® iFOBTest - 10743816001041 Catalog Number : BSP-300-25-00

Device Description : BioSign® iFOBTest; 25 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Status iFOBTest - 10743816001058 Catalog Number : BSP-300-30-00

Device Description : Status iFOBTest (30 Tests/50 Tubes/50 Mailers)

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Status iFOBTest Device Refill - 10743816001072 Catalog Number : BSP-300-D

Device Description : Status iFOBTest Device Refill (50)

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Status iFOBTest - 10743816001089 Catalog Number : BSP-300-05-00

Device Description : Status iFOBTest (5 Tests/5 Tubes/5 Mailers)

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

Status iFOBTest Collection Tube Kit - 10743816001096 Catalog Number : BSP-300-TU-01

Device Description : Status iFOBTest Collection Tube Kit (50Tubes)

Device Class :

Duns Number: 362917692

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Status iFOBTest Control Kit - 10743816001102 Catalog Number : BSP-300-C-01

Device Description : Status iFOBTest Control Kit (1 Pos/1 Neg)

Device Class :

Duns Number: 362917692

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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