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

Antigens, All Groups, Streptococcus Spp. (GTY) (9) Radioimmunoassay, Luteinizing Hormone (CEP) (1)

Premarket Exempt

Yes No

Clear

OvuSign® LH card - 10743816000778 Catalog Number : OSH-143-35-01

Device Description : OvuSign® LH card; 35 Test Kit; CE

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 1

Status Strep A Flip - 10743816000785 Catalog Number : BSP-182-25-00

Device Description : Status Strep A card; Flip cassette; 25 Test kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

Status AccuStrep A card - 10743816000792 Catalog Number : BSP-181-25-01

Device Description : Status AccuStrep A card; 25 Test kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

BioSign® Strep A card - 10743816000808 Catalog Number : BSP-181-25-02

Device Description : BioSign® Strep A card; 25 Test kit; CE

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

BioSign® Strep A card - 10743816000815 Catalog Number : BSP-182-25-02

Device Description : BioSign® Strep A card; Flip cassette; 25 Test kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

BioSign® Strep A Flip - 10743816000822 Catalog Number : BSP-182-25-03

Device Description : BioSign® Strep A card; Flip cassette; 25 Test kit; for LifeSign (Infolab)

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

Status Strep A Flip - 10743816000839 Catalog Number : BSP-182-05-00

Device Description : Status Strep A card; Flip cassette; 5 Test kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

Status Strep A Flip - 10743816000846 Catalog Number : BSP-182-12-00

Device Description : Status Strep A card; Flip cassette; 12 Test sample kit

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

Status Strep A Plus - 10743816000853 Catalog Number : BSP-185-50-01

Device Description : Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister)

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

Status Strep A Plus - 10743816000860 Catalog Number : BSP-185-05-00

Device Description : Status Strep A Plus; 5 Test kit (5 Test Strip Canister)

Device Class : 1

Duns Number: 362917692

Premarket Exempt : No

Product Code : GTY

Prescription Use : No

Device Count : 1

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