MENARINI SILICON BIOSYSTEMS, INC.

Address:3401 Masons Mill road,Huntingdon Valley,PA,19006,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

SYSTEM, IMMUNOMAGNETIC, CIRCULATING CANCER CELL, ENUMERATION (NQI) (7) Tubes, vials, systems, serum separators, blood collection (JKA) (2) CONTROL MATERIAL, BLOOD CIRCULATING EPITHELIAL CANCER CELL (NRS) (1)

Premarket Exempt

Clear

CellSearch - 10888385000016 Catalog Number : 7900001

Device Description : Circulating Tumor Cell Kit (Epithelial)

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

CellSearch - 10888385000023 Catalog Number : 7900003

Device Description : Circulating Tumor Cell Control Cell Kit

Device Class :

Duns Number: 057722858

Premarket Exempt : No

Product Code : NRS

Prescription Use : Yes

Device Count : 24

CellSave - 10888385000030 Catalog Number : 952820

Device Description : Preservative Tube 20 pack

Device Class :

Duns Number: 057722858

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 20

CellSave - 10888385000047 Catalog Number : 7900005

Device Description : Preservative Tube 100 Pack

Device Class :

Duns Number: 057722858

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 100

CELLTRACKS ANALYZER II - 10888385000054 Catalog Number : 9555

Device Description : CellTracks Analyzer II

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

CELLTRACKS AUTOPREP - 10888385000061 Catalog Number : 9541

Device Description : AutoPrep Instrument

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

CELLTRACKS AUTOPREP - 10888385000078 Catalog Number : 7901003

Device Description : CellTracks AutoPrep Instrument Buffer

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

CELLTRACKS ANALYZER II - 10888385000085 Catalog Number : 9542

Device Description : Remote Review Work Station

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

CELLTRACKS AUTOPREP - 10888385000610 Catalog Number : 9541R

Device Description : AutoPrep Instrument- Refurbished

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

CELLTRACKS ANALYZER II - 10888385000627 Catalog Number : 9555R

Device Description : CellTracks Analyzer II - Refurbished

Device Class : 2

Duns Number: 057722858

Premarket Exempt : No

Product Code : NQI

Prescription Use : Yes

Device Count : 1

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