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) (4)

Premarket Exempt

Yes No

Clear

BioSign® hCG card - 10743816000570 Catalog Number : BSP-121-35-03

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

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

BioSign® hCG card - 10743816000587 Catalog Number : BSP-121-10-01

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

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

Status hCG card - 10743816000594 Catalog Number : BSP-121-35-06

Device Description : Status hCG card; 35 Test kit; Narrow device

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

BioSign® hCG card - 10743816000600 Catalog Number : BSP-121-35-07

Device Description : BioSign® hCG card; 35 Test kit; CE; Narrow Device

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

BioSign® hCG card - 10743816000617 Catalog Number : BSP-121-35-10

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

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

Status hCG controls - 10743816000624 Catalog Number : BSP-121C-00

Device Description : Status hCG Pos/Neg controls (2 x 2.5 mL)

Device Class :

Duns Number: 362917692

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Status™ hCG S/U card - 10743816000631 Catalog Number : BSP-120S-35-01

Device Description : Status™ hCG S/U card; LifeSign; 35 Test kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

Status™ hCG S/U card - 10743816000648 Catalog Number : BSP-120S-12-00

Device Description : Status™ hCG S/U card; 12 Test sample kit

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

BioSign® hCG S/U card - 10743816000655 Catalog Number : BSP-120S-35-04

Device Description : BioSign® 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® hCG S/U card - 10743816000662 Catalog Number : BSP-120S-10-01

Device Description : BioSign® hCG S/U card; 10 Test kit; CE

Device Class : 2

Duns Number: 362917692

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

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