AccessGUDID - DEVICE: CELLTRACKS ANALYZER II (10888385000627)

GUDID

Device Identifier (DI) Information

Brand Name: CELLTRACKS ANALYZER II
Version or Model: 9555R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9555R
Company Name: MENARINI SILICON BIOSYSTEMS, INC.

Primary DI Number: 10888385000627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057722858 *Terms of Use

Device Description: CellTracks Analyzer II - Refurbished

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56706	Fluorescent immunoassay analyser IVD, laboratory, semi-automated	A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 50 Degrees Celsius
Special Storage Condition, Specify: Fragile.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddd1ea87-a56d-49df-b7b2-8e905f85d9a6
Public Version Date: February 07, 2019
Public Version Number: 3
DI Record Publish Date: September 22, 2016