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

System, Test, Human Chorionic Gonadotropin (DHA) (5) Visual, Pregnancy Hcg, Prescription Use (JHI) (5)

Premarket Exempt

Yes No

Clear

BioSign® hCG S/U card - 10743816000679 Catalog Number : BSP-120S-35-09

Device Description : BioSign® hCG S/U card; 35 Test kit; CE; E-device for Lifesign

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

Status™ hCG S/U card - 10743816000686 Catalog Number : BSP-120S-10-03

Device Description : Status™ hCG S/U card; LifeSign; 10 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

StatusFirst™ hCG S/U card - 10743816000693 Catalog Number : BSP-122-35-02

Device Description : StatusFirst™ hCG S/U card; for reader; LifeSign; 35 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

BioSign® RC hCG S/U card - 10743816000709 Catalog Number : BSP-122-35-00

Device Description : BioSign® RC hCG S/U card; 35 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

BioSign® RC hCG S/U card - 10743816000716 Catalog Number : BSP-122-35-01

Device Description : BioSign® RC hCG S/U card; 35 Test kit; E Device; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

BioStrip® P - 10743816000723 Catalog Number : BXI-113-00-00

Device Description : BioStrip® P; 100 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

Status™ hCG strip - 10743816000730 Catalog Number : BXI-113-35-00

Device Description : Status™ hCG strip; 35 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

BioStrip® P - 10743816000747 Catalog Number : BXI-113-25-01

Device Description : BioStrip® P; 25 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

BioStrip® P - 10743816000754 Catalog Number : BXI-113-50-01

Device Description : BioStrip® P; 50 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

BioStrip® P - 10743816000761 Catalog Number : BXI-113-25-02

Device Description : BioStrip® P; 25 Test kit; CE (for LifeSign)

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

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