AccessGUDID - DEVICE: Advanced Instruments GloCyte® Test Cartridge Kit

GUDID

Device Identifier (DI) Information

Brand Name: Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays
Version or Model: 111010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 111010
Company Name: ADVANCED INSTRUMENTS, INC.

Primary DI Number: 20816068020201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 125006353 *Terms of Use

Device Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35476	Haematological cell analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKL	Counter, Cell, Automated (Particle Counter)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152776	000

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 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 112266c7-9dd2-4115-b843-b3600ff350d2
Public Version Date: May 16, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016