FDA UDI In Commercial Distribution 🇺🇸 United States

CELLTRACKS ANALYZER II

DI: 10888385000085 · Model: 9542 · MENARINI SILICON BIOSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CELLTRACKS ANALYZER II
Primary DI
10888385000085
Version / Model
9542
Catalog Number
9542
Company Name
MENARINI SILICON BIOSYSTEMS, INC.
Labeler DUNS
057722858
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-22
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
34993af7-52c8-4886-8900-257e68c2be10

Device Description

Remote Review Work Station

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NQI SYSTEM, IMMUNOMAGNETIC, CIRCULATING CANCER CELL, ENUMERATION

GMDN Terms

Code Name
56706 Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Identifiers

Type ID
Primary 10888385000085

Customer Contacts

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Fragile.